US20150366311A1 - Protection of Contact Lenses from Microbial Contamination Caused by Handling - Google Patents

Protection of Contact Lenses from Microbial Contamination Caused by Handling Download PDF

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Publication number
US20150366311A1
US20150366311A1 US14/719,341 US201514719341A US2015366311A1 US 20150366311 A1 US20150366311 A1 US 20150366311A1 US 201514719341 A US201514719341 A US 201514719341A US 2015366311 A1 US2015366311 A1 US 2015366311A1
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Prior art keywords
contact lens
package
packaging solution
εpll
lens
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US14/719,341
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Inna Maltseva
Carol Ann Morris
Kathleen Khong
Andrew Luk
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CooperVision International Ltd
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CooperVision International Holding Co LP
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Priority to US14/719,341 priority Critical patent/US20150366311A1/en
Publication of US20150366311A1 publication Critical patent/US20150366311A1/en
Assigned to COOPERVISION, INC. reassignment COOPERVISION, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MALTSEVA, Inna, MORRIS, CAROL ANN, KHONG, Kathleen, LUK, ANDREW
Assigned to COOPERVISION INTERNATIONAL HOLDING COMPANY, LP reassignment COOPERVISION INTERNATIONAL HOLDING COMPANY, LP ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: COOPERVISION, INC.
Assigned to COOPERVISION INTERNATIONAL LIMITED reassignment COOPERVISION INTERNATIONAL LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: COOPERVISION INTERNATIONAL HOLDING COMPANY, LP
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45CPURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A45C11/005Contact lens cases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/645Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/086Container, accessories or devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/14Organic compounds not covered by groups A61L12/10 or A61L12/12
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • A61L2/28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00Disinfection, sterilisation or deodorisation of air
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00605Production of reflex reflectors
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B25/00Packaging other articles presenting special problems
    • B65B25/008Packaging other articles presenting special problems packaging of contact lenses
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/22Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient in moist conditions or immersed in liquids
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/0005Other compounding ingredients characterised by their effect
    • C11D3/0078Compositions for cleaning contact lenses, spectacles or lenses
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16Organic compounds
    • C11D3/37Polymers
    • C11D3/3703Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • C11D3/3719Polyamides or polyimides
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B5/00Optical elements other than lenses
    • G02B5/12Reflex reflectors
    • G02B5/122Reflex reflectors cube corner, trihedral or triple reflector type
    • G02B5/124Reflex reflectors cube corner, trihedral or triple reflector type plural reflecting elements forming part of a unitary plate or sheet

Definitions

  • the field of the invention is contact lenses packages.
  • Microbial contamination of contact lenses is a serious public health concern due to its implications in ocular infiltrates, infections and microbial keratitis.
  • Studies have demonstrated that lens handling greatly increases the incidence of microbial contamination of lenses see e.g. Szczotka-Flynn et al., Eye Contact Lens (2010) 36(2):116-29).
  • Daily disposable contact lens wearers can be particularly at risk for contamination due to the non-compliant storage of contact lenses after use in their original packaging solution and subsequent reuse (Boost et al., Optom Vis Sci (2011) 88(12:1409-13).
  • ⁇ -polylysine is a homopolymer of about 25-35 residues of L-lysine in which the epsilon-amino and carboxyl groups of L-Lysine are linked. It is a naturally-occurring polymer produced by Streptomyces species. It has broad-spectrum antimicrobial activity and has been widely used as a food preservative in Japan and as an additive in a variety of consumer products. The use of ⁇ -polylysine in contact lens care solutions has been described (see e.g. U.S. Pat. No. 6,187,264, and U.S. Pat. Publ. No. 2005/0074467). Antimicrobial hydrogels made from epsilon-poly-L-lysine-graft-methacrylamide have been reported (Zhou et al., Biomaterials 32 (2011) 2704-2712).
  • the invention provides a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution, said contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said ⁇ PLL.
  • PA Pseudomonas aeruginosa
  • the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
  • the contact lens package comprises (a) a plastic base member comprising a cavity which retains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL); and (b) a resealable cover that forms a liquid-tight seal with the plastic base member.
  • a plastic base member comprising a cavity which retains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL); and (b) a resealable cover that forms a liquid-tight seal with the plastic base member.
  • ⁇ PLL epsilon polylysine
  • a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL) in an amount effective to reduce or completely eliminate microbial contamination introduced to the lens during its removal from the package.
  • unworn means that the contact lens has never been placed on an eye
  • sealed means having a water-tight seal.
  • a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL) are provided.
  • the unworn contact lens exhibits reduced contamination from at least one microbe.
  • the reduced contamination can be determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said ⁇ PLL.
  • PA Pseudomonas aeruginosa
  • At least one microbe can comprise, consists of, consists essentially of, or include Pseudomonas aeruginosa and/or Staphylococcus aureus , and/or the at least one microbe is a microbe(s) found in microbial keratitis and/or at least one microbe causing at least in part or entirely ocular infiltrates and/or infections.
  • the contact lens sealed in the contact lens package of the present disclosure may be made from any contact lens material, including but not limited to conventional hydrogels and silicone hydrogels.
  • a “conventional hydrogel” refers to a material formed from polymerization of one or more hydrophilic monomers such as 2-hydroxyethyl methacrylate (HEMA) or vinyl alcohol, optionally in combination with other monomers, and contains no siloxane (i.e. a molecule comprising at least one Si—O group).
  • HEMA 2-hydroxyethyl methacrylate
  • vinyl alcohol optionally in combination with other monomers, and contains no siloxane (i.e. a molecule comprising at least one Si—O group).
  • siloxane i.e. a molecule comprising at least one Si—O group
  • Examples of conventional hydrogels include etafilcon A, nelfilcon A, ocufilcon B, ocufilcon D, omafilcon A, omafilcon D and
  • Silicone hydrogel materials are typically formed from polymerization of one or more monomers or prepolymers comprising at least one Si—O group with one or more hydrophilic monomers.
  • silicone hydrogels include balafilcon A, comfilcon A, enfilcon A, somofilcon A, narafilcon A, narafilcon B, lotrafilcon A, stenfilcon A, and senofilcon A.
  • the sealed contact lens package comprises a sterile, unworn silicone hydrogel contact lens.
  • the silicone hydrogel contact lens is non-ionic, meaning it that it contains no anionic groups that bind to the cationic amine groups present in the ⁇ PLL via ionic interaction.
  • the silicone hydrogel contact lens is made from a material selected from comfilcon A or stenfilcon A.
  • the sealed contact lens package comprises an unworn conventional hydrogel contact lens made from a material selected from ocufilcon B, ocufilcon D, or omafilcon A.
  • the contact lens sealed in the contact lens package of the present disclosure may be of any lens wear modality.
  • Lens wear modality refers to the how many days and nights in a row the lens can be worn without removal.
  • the contact lens sealed in the contact lens package of the present disclosure is a daily disposable lens. Daily disposable lenses are indicated for single use, up to about 12 or 16 hours of continuous wear, and should be discarded after the single use.
  • the contact lens sealed in the contact lens package of the present disclosure is a daily wear lens. Daily wear lenses are worn during the waking hours, typically up to about 12 to 16 hours, and are removed before sleep. Daily wear lenses are typically stored in a contact lens case containing a contact lens care solution for cleaning and disinfecting the lens during the hours of non-use. Daily wear lenses are typically discarded after a maximum of 30 days wear.
  • the contact lens is an extended wear lens. Extended wear lenses are typically worn continuously for up to 6, 14 or 30 consecutive days and nights.
  • the packaging solution sealed within the contact lens package of the present disclosure may be any contact-lens compatible solution comprising an effective amount of ⁇ PLL.
  • the packaging solution comprises, consists, or consists essentially, of an aqueous solution of a buffer, and/or a tonicity agent, and ⁇ PLL.
  • the packaging solution contains additional agents such as one or more additional antimicrobial agents, and/or a comfort agent, and/or a hydrophilic polymer, and/or a surfactant and/or other additive that prevents the lens from sticking to the package.
  • the packaging solution can have a pH in the range of about 6.8 or 7.0 up to about 7.8 or 8.0.
  • the packaging solution comprises phosphate buffer or borate buffer.
  • the packaging solution comprises a tonicity agent selected from sodium chloride or sorbitol in an amount to maintain osmolality in the range of about 200 to 400 mOsm/kg, and typically from about 270 mOsm/kg up to about 310 mOsm/kg.
  • a reference to “examples”, “an example”, “one example”, or similar phrase is intended to introduce a feature or features of the contact lens package, unworn contact lens, or packaging solution, as the case may be (depending on context) that can be combined with any combination of previously-described or subsequently-described examples (i.e. features), unless a particular combination of features is mutually exclusive, or if context indicates otherwise.
  • An effective amount of ⁇ PLL is an amount that reduces microbial contamination introduced to the lens during its removal from the contact lens package (e.g., as compared to no ⁇ PLL present).
  • the ability of ⁇ PLL to reduce microbial contamination introduced to a lens during its removal from a package can be demonstrated using methodology substantially as described in Example 1 or Example 2 below.
  • Example 1 demonstrates that microbial contamination of contact lenses caused by normal, non-pathogenic skin flora can be significantly reduced by inclusion of ⁇ PLL in the contact lens packaging solution.
  • Example 2 demonstrates that microbial contamination of contact lenses caused by Pseudomonas aeruginosa (PA), one of the most common pathogens implicated in microbial keratitis, can also be significantly reduced by inclusion of ⁇ PLL in the contact lens packaging solution.
  • PA Pseudomonas aeruginosa
  • the unworn contact lens exhibits reduced contamination from PA introduced to the lens during removal from the packaging solution compared to a control contact lens in the same packaging comprising a contact lens packaging solution without ⁇ PLL but otherwise identical, as determined using a lens handling assay as described or substantially as described in Example 2.
  • the packaging solution comprises ⁇ PLL in amounts of at least 5 ppm, 10 ppm, 25 ppm, 50 ppm, 100 ppm, 150 ppm, 200 ppm, 250 ppm, or 500 ppm.
  • the packaging solution comprises 10-50 ppm ⁇ PLL, 25-75 ppm ⁇ PLL, 50-150 ppm ⁇ PLL, or 100-500 ppm ⁇ PLL.
  • the concentration of ⁇ PLL in a packaging solution is determined prior to its contact with the unworn contact lens.
  • ⁇ PLL is commercially available typically as a homopolymer ranging from about 25 to about 35 lysine (LYS) residues (CAS no. 28211-04-3). All fractions of the naturally-occurring homopolymer of ⁇ PLL may be used. Alternatively, a select fraction of the ⁇ PLL may be used (e.g. a homopolymer of 30-35 LYS residues) with the remaining fractions removed and not used in this option. As an alternative to naturally-occurring ⁇ PLL, the ⁇ PLL used in the packaging solution may be obtained from synthetic peptide methods.
  • LYS lysine residues
  • the amount of ⁇ PLL included in the contact lens packaging solution results in less than a two log kill of PA compared to a control contact lens when tested after 24 hours incubation with 10 4 CFU (colony-forming units) PA as determined using an in vitro bioactivity assay substantially as described in Example 4 below.
  • the contact lens package remains effective against microbial contamination introduced from initial handling of the lens during its removal from its original packaging, and thus is particularly suitable for a daily disposable contact lens.
  • the contact lens package described herein can provide protection against microbial contamination that might arise from a non-compliant daily lens wearer who stores a worn lens overnight in its original package and remaining packaging solution for a second day of wear.
  • the contact lens package comprises a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a flange region extending outwardly around the cavity. A removable foil is attached to the flange region to provide a sealed contact lens package.
  • the contact lens package comprises a contact lens indicated for daily wear for at least 2 days, wherein the package is configured to allow resealing after its initial opening for subsequent replacement of the lens for overnight storage after it has been worn.
  • the contact lens package may comprise a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a resealable cover.
  • a “resealable cover” is one that is configured to form a liquid-tight or spill-proof seal with the base member after the contact lens package is opened.
  • the plastic base member may comprise a plurality of threads for engagement with a compatible set of threads on a cap which serves as the resealable cover.
  • Such configurations are commonly used in contact lens care cases (see e.g. U.S. Pat. No. 3,977,517).
  • an advantage of the contact lens package disclosed herein is that it can serve a dual purpose, i.e. both as a contact lens package for a sterile, unworn contact lens and as a subsequent contact lens carrying case for a worn lens.
  • a method of manufacturing a contact lens package including the step of placing an unworn contact lens and a contact lens packaging solution comprising ⁇ PLL in a receptacle, placing a cover on the receptacle, and sealing the cover on the receptacle.
  • the receptacle is configured to receive a single contact lens and an amount of packaging solution sufficient to completely cover the contact lens, typically about 0.5-1.5 ml.
  • the receptacle may be made from any suitable material, such as glass or plastic.
  • the receptacle comprises a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a flange region extending outwardly around the cavity, and the cover comprises a removable foil attached to the flange region to provide the sealed contact lens package.
  • the removable foil may be sealed by any conventional means such as heat sealing or gluing.
  • the receptacle is in the form of a plastic base member comprising a plurality of threads and the cover comprises a plastic cap member comprising a compatible set of thread for engagement with the threads of the base member thereby providing a resealable cover.
  • the contact lens package may comprise a plastic cover comprising features that engage with compatible features of the receptacle to form an interference fit.
  • the method of manufacturing the sealed contact lens package may further comprise sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
  • balafilcon A contact lenses in their original blister packaging were used in this lens-handling study.
  • Five individuals washed their hands with soap and water and dried their hands using paper towels.
  • the foil cover of each blister was opened aseptically with a gloved hand by the investigator.
  • Each individual removed and gently rubbed the lens for approximately 5 seconds using the same hand used to turn off the faucet.
  • Each rubbed lens was then placed into an individual sterile 2 mL microcentrifuge (EppendorfTM) tube with 1 mL PBS-T and capped.
  • PBS refers phosphate buffered saline of 0.78 wt. % NaCl, 0.05 wt. % sodium phosphate monobasic, and 0.36 wt. % sodium phosphate dibasic at pH 7.5.
  • PBS-T refers to PBS with 0.05% Polysorbate 80.
  • the tubes were sonicated for 3 cycles of 30 seconds each with 10 seconds vortexing in between. After the final sonication the tubes were vortexed for 10 minutes at 1000 rpm using a multi-tube vortexer. The entire volume of extract from each tube was plated onto a blood agar plate, allowed to dry in a biochemical hood, and incubated at 37° C. for 48-72 hours. Bacteria were counted and reported as CFU/lens. Each bacterium with a distinct phenotype was identified using a Biotyper.
  • Detectable levels of contamination from common skin bacteria were found on all five balafilcon A contact lenses. The range of contamination was from 115-6500 CFU/lens. No lens was sterile. Although the identified bacteria are not commonly found in microbial keratitis, they can cause disease in immune-compromised patients.
  • ⁇ PLL in a contact lens packaging solution would be protective immediately against microbes deposited during lens removal from a blister package
  • the above lens-handling study was repeated using ocufilcon D, comfilcon A, and omafilcon A contact lenses that had been individually packaged in a contact lens blister package containing a packaging solution of either PBS or PBS with 500 ppm ⁇ PLL, sealed with a foil cover, and autoclaved. All three lenses demonstrated a significant reduction in bioburden when ⁇ PLL was present in the packaging solution, with the following average log kill: ocufilcon D—2.4, comfilcon A—1.4, and omafilcon A—2.2.
  • the bacterial adherence onto the surface of comfilcon A lenses removed from autoclaved blister packages containing a packaging solution of PBS with or without ⁇ PLL (10, 25, 100, or 500 ppm) was evaluated using a modification of methods described by Nomachi et al., Eye & Contact Lens (2013) 39:234-238. Briefly, the bacterial adherence onto the surface of comfilcon A contact lenses was evaluated using stock solutions of Pseudomona aeruginosa (PA) and Staphylococcus aureus (SA) prepared substantially as described in Example 3 below. Sterile surgical plastic gloves were put on both hands aseptically.
  • PA Pseudomona aeruginosa
  • SA Staphylococcus aureus
  • the thumb and index finger of a hand gloved were dipped into the bacterial suspension (approximately 10 3 CFU/ml in PBS) and used to remove a lens from a package.
  • the bacterial suspension approximately 10 3 CFU/ml in PBS
  • Four lenses of each type of packaging solution were tested. Each lens was placed into a microcentrifuge tube with 1 mL PBS-T, sonicated for 1.5 minute and vortexed for 10 minutes at 1000 rpm.
  • the entire volume of the extract was plated onto a culture dish with tryptic soy agar (TSA) and grown at 37° C. for 2 days in an incubator.
  • TSA tryptic soy agar
  • the blister package and remaining packaging solution were left covered with the original blister foil at ambient temperature. After 16 hours, the entire volume of remaining packaging solution ( ⁇ 1 mL) was plated onto a culture dish with TSA and left in an incubator at 37° C. for 2 days to grow.
  • the packaging solution without any added ePL had an average of 331 CFU/Lens. None of the ePL-containing packaging solutions exhibited microbial growth, i.e. all had 0 CFU/Lens.
  • Cultures were prepared from growing a single colony of each of the bacterial species shown in Table 3 below in 50 mL. trypticase soy broth (TSB) overnight at 37° C. on a rotary shaker. 1 mL of each culture was centrifuged, and the bacterial pellet resuspended in 1.0 mL of the diluent shown in Table 3. For each bacterial species, a suspension of approximately 10 8 CFU/mL was prepared by diluting the bacterial suspension to achieve the optical density indicated in Table 3. Each suspension is further diluted for use in the handling assay described in Example 2 or the in vitro bioactivity assay described in Example 4.
  • TAB trypticase soy broth
  • a contact lens is removed from its packaging and rinsed in 2.5 ml sterile PBS for a few seconds to remove residual packaging solution.
  • the rinsed lens is then transferred to an individual well of a 24-well plate containing 1.0 mL of 10 4 CFU PA.
  • the plate is incubated at 37° C. with gentle shaking for 24 hours.
  • the lens is removed from its well and transferred to a well of a 12-well plate containing 2.5 mL of sterile PBS.
  • the plate is gently swirled for about 30 seconds. This step is repeated once for each lens.
  • Each washed lens is placed in a microcentrifuge tube containing 1 mL of Dey-Engley (DE) neutralizing broth and adhered bacteria are removed by a combination of sonication for about 2 minutes and vortexing for about 10 minutes.
  • Serial dilutions are made for each recovered cell suspension using DE neutralizing broth and suitable dilutions are plated onto TSA. Plates are incubated overnight at 37° C. and CFUs are counted.
  • DE Dey-Engley
  • the CFU for each plate is multiplied by the dilution factor (DF) as well as the plating dilution factor (PDF).
  • the total CFUs recovered for a given sample are then converted to the log 10.
  • the present invention includes the following aspects/embodiments/features in any order and/or in any combination:
  • a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL), wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without ⁇ PLL.
  • PA Pseudomonas aeruginosa
  • a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine ( ⁇ PLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said ⁇ PLL.
  • PA Pseudomonas aeruginosa
  • the package of any preceding or following embodiment/feature/aspect wherein, in the test, the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 10 4 CFU PA using an in vitro bioactivity assay. 4. The package of any preceding or following embodiment/feature/aspect, wherein, in the test, the unworn contact less results in less than a one log kill of PA (but more than a zero log kill) compared to the control contact lens when tested after 24 hours incubation with 10 4 CFU PA using an in vitro bioactivity assay. 5. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a silicone hydrogel contact lens. 6.
  • the package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a non-ionic contact lens. 7. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is an ionic contact lens. 8. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a daily disposable contact lens. 9. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a daily wear contact lens. 10. The package of any preceding or following embodiment/feature/aspect, wherein the packaging solution comprises between 5 ppm and 500 ppm ⁇ PLL. 11. The package of any preceding or following embodiment/feature/aspect, wherein the packaging solution comprises between 5 ppm and 50 ppm ⁇ PLL. 12.
  • the contact lens package further comprises (a) a plastic base member comprising i) a cavity which retains the unworn contact lens and the contact lens packaging solution, and ii) a flange region extending outwardly around the cavity; and (b) a removable foil attached to the flange region.
  • the contact lens package further comprises (a) a plastic base member comprising a cavity which retains the unworn contact lens and the contact lens packaging solution; and (b) a resealable cover that forms a liquid-tight seal with the plastic base member.
  • the plastic base member comprises a plurality of threads for engagement with a compatible set of threads on the resealable cover.
  • the at least one microbe is Pseudomonas aeruginosa.
  • the at least one microbe is Staphylococcus aureus.
  • the at least one microbe is a microbe found in microbial keratitis. 18.
  • a method of manufacturing the sealed contact lens package comprising placing an unworn contact lens and a contact lens packaging solution comprising ⁇ PLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without ⁇ PLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 10 4 CFU PA using an in vitro bioactivity assay.
  • PA Pseudomonas aeruginosa
  • a method of manufacturing the sealed contact lens package comprising placing an unworn contact lens and a contact lens packaging solution comprising ⁇ PLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said ⁇ PLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 10 4 CFU PA using an in vitro bioactivity assay.
  • PA Pseudomonas aeruginosa
  • a method of manufacturing the sealed contact lens package comprising placing an unworn contact lens and a contact lens packaging solution comprising ⁇ PLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without ⁇ PLL, and wherein the contact lens package comprises a resealable cover.
  • PA Pseudomonas aeruginosa
  • a method of manufacturing the sealed contact lens package comprising placing an unworn contact lens and a contact lens packaging solution comprising ⁇ PLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said ⁇ PLL, and wherein the contact lens package comprises a resealable cover.
  • PA Pseudomonas aeruginosa
  • any preceding or following embodiment/feature/aspect wherein the contact lens package is any one of 1 through 17. 25. The method of any preceding or following embodiment/feature/aspect, further comprising sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
  • the present invention can include any combination of these various features or embodiments above and/or below as set forth in sentences and/or paragraphs. Any combination of disclosed features herein is considered part of the present invention and no limitation is intended with respect to combinable features.

Abstract

A sealed contact lens package contains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL). The εPLL protects the contact lens from microbial contamination caused by handling the lens when it is removed from its package.

Description

  • This application claims the benefit under 35 U.S.C. §119(e) of prior U.S. Provisional Patent Application No. 62/014,348, filed Jun. 19, 2014, which is incorporated in its entirety by reference herein.
  • FIELD
  • The field of the invention is contact lenses packages.
  • BACKGROUND
  • Microbial contamination of contact lenses is a serious public health concern due to its implications in ocular infiltrates, infections and microbial keratitis. Studies have demonstrated that lens handling greatly increases the incidence of microbial contamination of lenses (see e.g. Szczotka-Flynn et al., Eye Contact Lens (2010) 36(2):116-29). Daily disposable contact lens wearers can be particularly at risk for contamination due to the non-compliant storage of contact lenses after use in their original packaging solution and subsequent reuse (Boost et al., Optom Vis Sci (2011) 88(12:1409-13).
  • ε-polylysine is a homopolymer of about 25-35 residues of L-lysine in which the epsilon-amino and carboxyl groups of L-Lysine are linked. It is a naturally-occurring polymer produced by Streptomyces species. It has broad-spectrum antimicrobial activity and has been widely used as a food preservative in Japan and as an additive in a variety of consumer products. The use of ε-polylysine in contact lens care solutions has been described (see e.g. U.S. Pat. No. 6,187,264, and U.S. Pat. Publ. No. 2005/0074467). Antimicrobial hydrogels made from epsilon-poly-L-lysine-graft-methacrylamide have been reported (Zhou et al., Biomaterials 32 (2011) 2704-2712).
  • Other background publications include co-pending U.S. patent application Ser. No. 14/109,976, U.S. Pat. Publ. No. 2012/0074352, U.S. Pat. Publ. No. 2011/0071091, U.S. Pat. Publ. No. 2005/0074467, U.S. Pat. Publ. No. 2004/0135967, U.S. Pat. No. 4,168,112, U.S. Pat. No. 7,282,214, U.S. Pat. No. 7,402,318, EP Pat. No. 1328303B1, and PCT Publ. No. WO94/13774.
  • SUMMARY
  • The invention provides a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution, said contact lens packaging solution comprising epsilon polylysine (εPLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL. In one aspect of the invention, in the test, the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay. In another aspect of the invention, the contact lens package comprises (a) a plastic base member comprising a cavity which retains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL); and (b) a resealable cover that forms a liquid-tight seal with the plastic base member.
  • DETAILED DESCRIPTION
  • We demonstrate that the initial removal of contact lenses from their original sterile packaging can result in significant microbial contamination of the lenses, even when handled immediately after hand washing. We have found that the addition of epsilon polylysine (εPLL) to the contact lens packaging solution can reduce or completely eliminate such lens-handling contamination. Disclosed herein is a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL) in an amount effective to reduce or completely eliminate microbial contamination introduced to the lens during its removal from the package. As used herein, “unworn” means that the contact lens has never been placed on an eye, and “sealed” means having a water-tight seal.
  • With the present invention, a sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL) are provided. The unworn contact lens exhibits reduced contamination from at least one microbe. The reduced contamination can be determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL. In the present invention, at least one microbe can comprise, consists of, consists essentially of, or include Pseudomonas aeruginosa and/or Staphylococcus aureus, and/or the at least one microbe is a microbe(s) found in microbial keratitis and/or at least one microbe causing at least in part or entirely ocular infiltrates and/or infections.
  • The contact lens sealed in the contact lens package of the present disclosure may be made from any contact lens material, including but not limited to conventional hydrogels and silicone hydrogels. As used herein, a “conventional hydrogel” refers to a material formed from polymerization of one or more hydrophilic monomers such as 2-hydroxyethyl methacrylate (HEMA) or vinyl alcohol, optionally in combination with other monomers, and contains no siloxane (i.e. a molecule comprising at least one Si—O group). Examples of conventional hydrogels include etafilcon A, nelfilcon A, ocufilcon B, ocufilcon D, omafilcon A, omafilcon D and polymacon. Silicone hydrogel materials are typically formed from polymerization of one or more monomers or prepolymers comprising at least one Si—O group with one or more hydrophilic monomers. Examples of silicone hydrogels include balafilcon A, comfilcon A, enfilcon A, somofilcon A, narafilcon A, narafilcon B, lotrafilcon A, stenfilcon A, and senofilcon A. In a specific example, the sealed contact lens package comprises a sterile, unworn silicone hydrogel contact lens. In a specific example, the silicone hydrogel contact lens is non-ionic, meaning it that it contains no anionic groups that bind to the cationic amine groups present in the εPLL via ionic interaction. In a further specific example, the silicone hydrogel contact lens is made from a material selected from comfilcon A or stenfilcon A. In another example, the sealed contact lens package comprises an unworn conventional hydrogel contact lens made from a material selected from ocufilcon B, ocufilcon D, or omafilcon A.
  • The contact lens sealed in the contact lens package of the present disclosure may be of any lens wear modality. Lens wear modality refers to the how many days and nights in a row the lens can be worn without removal. In one example, the contact lens sealed in the contact lens package of the present disclosure is a daily disposable lens. Daily disposable lenses are indicated for single use, up to about 12 or 16 hours of continuous wear, and should be discarded after the single use. In another example, the contact lens sealed in the contact lens package of the present disclosure is a daily wear lens. Daily wear lenses are worn during the waking hours, typically up to about 12 to 16 hours, and are removed before sleep. Daily wear lenses are typically stored in a contact lens case containing a contact lens care solution for cleaning and disinfecting the lens during the hours of non-use. Daily wear lenses are typically discarded after a maximum of 30 days wear. In yet another example, the contact lens is an extended wear lens. Extended wear lenses are typically worn continuously for up to 6, 14 or 30 consecutive days and nights.
  • The packaging solution sealed within the contact lens package of the present disclosure may be any contact-lens compatible solution comprising an effective amount of εPLL. In one example, the packaging solution comprises, consists, or consists essentially, of an aqueous solution of a buffer, and/or a tonicity agent, and εPLL. In another example, the packaging solution contains additional agents such as one or more additional antimicrobial agents, and/or a comfort agent, and/or a hydrophilic polymer, and/or a surfactant and/or other additive that prevents the lens from sticking to the package. The packaging solution can have a pH in the range of about 6.8 or 7.0 up to about 7.8 or 8.0. In one example, the packaging solution comprises phosphate buffer or borate buffer. In another example, the packaging solution comprises a tonicity agent selected from sodium chloride or sorbitol in an amount to maintain osmolality in the range of about 200 to 400 mOsm/kg, and typically from about 270 mOsm/kg up to about 310 mOsm/kg. Throughout this disclosure a reference to “examples”, “an example”, “one example”, or similar phrase, is intended to introduce a feature or features of the contact lens package, unworn contact lens, or packaging solution, as the case may be (depending on context) that can be combined with any combination of previously-described or subsequently-described examples (i.e. features), unless a particular combination of features is mutually exclusive, or if context indicates otherwise.
  • An effective amount of εPLL is an amount that reduces microbial contamination introduced to the lens during its removal from the contact lens package (e.g., as compared to no εPLL present). The ability of εPLL to reduce microbial contamination introduced to a lens during its removal from a package can be demonstrated using methodology substantially as described in Example 1 or Example 2 below. Example 1 demonstrates that microbial contamination of contact lenses caused by normal, non-pathogenic skin flora can be significantly reduced by inclusion of εPLL in the contact lens packaging solution. Example 2 demonstrates that microbial contamination of contact lenses caused by Pseudomonas aeruginosa (PA), one of the most common pathogens implicated in microbial keratitis, can also be significantly reduced by inclusion of εPLL in the contact lens packaging solution. In a specific example, the unworn contact lens exhibits reduced contamination from PA introduced to the lens during removal from the packaging solution compared to a control contact lens in the same packaging comprising a contact lens packaging solution without εPLL but otherwise identical, as determined using a lens handling assay as described or substantially as described in Example 2. In various examples, the packaging solution comprises εPLL in amounts of at least 5 ppm, 10 ppm, 25 ppm, 50 ppm, 100 ppm, 150 ppm, 200 ppm, 250 ppm, or 500 ppm. In specific examples, the packaging solution comprises 10-50 ppm εPLL, 25-75 ppm εPLL, 50-150 ppm εPLL, or 100-500 ppm εPLL. The concentration of εPLL in a packaging solution is determined prior to its contact with the unworn contact lens.
  • εPLL is commercially available typically as a homopolymer ranging from about 25 to about 35 lysine (LYS) residues (CAS no. 28211-04-3). All fractions of the naturally-occurring homopolymer of εPLL may be used. Alternatively, a select fraction of the εPLL may be used (e.g. a homopolymer of 30-35 LYS residues) with the remaining fractions removed and not used in this option. As an alternative to naturally-occurring εPLL, the εPLL used in the packaging solution may be obtained from synthetic peptide methods.
  • In some examples the amount of εPLL included in the contact lens packaging solution results in less than a two log kill of PA compared to a control contact lens when tested after 24 hours incubation with 104 CFU (colony-forming units) PA as determined using an in vitro bioactivity assay substantially as described in Example 4 below. In such example the contact lens package remains effective against microbial contamination introduced from initial handling of the lens during its removal from its original packaging, and thus is particularly suitable for a daily disposable contact lens.
  • We demonstrate in Example 2 below that once the unworn contact lens is removed from the contact lens package the remaining packaging solution when covered up by the original blister foil can resist microbial contamination when left at ambient temperature for up to 16 hours. Thus, the contact lens package described herein can provide protection against microbial contamination that might arise from a non-compliant daily lens wearer who stores a worn lens overnight in its original package and remaining packaging solution for a second day of wear. Thus, in one example, the contact lens package comprises a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a flange region extending outwardly around the cavity. A removable foil is attached to the flange region to provide a sealed contact lens package. Such contact lens packages, which are commonly referred to as “blister packs”, are well-known in the art (see e.g. U.S. Pat. No. 7,426,993). In other examples, the contact lens package comprises a contact lens indicated for daily wear for at least 2 days, wherein the package is configured to allow resealing after its initial opening for subsequent replacement of the lens for overnight storage after it has been worn. For example, the contact lens package may comprise a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a resealable cover. As used herein, a “resealable cover” is one that is configured to form a liquid-tight or spill-proof seal with the base member after the contact lens package is opened. For example, the plastic base member may comprise a plurality of threads for engagement with a compatible set of threads on a cap which serves as the resealable cover. Such configurations are commonly used in contact lens care cases (see e.g. U.S. Pat. No. 3,977,517). Thus an advantage of the contact lens package disclosed herein is that it can serve a dual purpose, i.e. both as a contact lens package for a sterile, unworn contact lens and as a subsequent contact lens carrying case for a worn lens.
  • It will be appreciated that conventional manufacturing methods can be used to manufacture the sealed contact lens package of any of the above examples. Thus, in one aspect of the present disclosure is a method of manufacturing a contact lens package including the step of placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle, placing a cover on the receptacle, and sealing the cover on the receptacle. Generally, the receptacle is configured to receive a single contact lens and an amount of packaging solution sufficient to completely cover the contact lens, typically about 0.5-1.5 ml. The receptacle may be made from any suitable material, such as glass or plastic. In one example, the receptacle comprises a plastic base member comprising a cavity configured to retain the contact lens and packaging solution and a flange region extending outwardly around the cavity, and the cover comprises a removable foil attached to the flange region to provide the sealed contact lens package. The removable foil may be sealed by any conventional means such as heat sealing or gluing. In another example, the receptacle is in the form of a plastic base member comprising a plurality of threads and the cover comprises a plastic cap member comprising a compatible set of thread for engagement with the threads of the base member thereby providing a resealable cover. It will be appreciated that other types of packaging can also be used to provide a resealable package. For example the contact lens package may comprise a plastic cover comprising features that engage with compatible features of the receptacle to form an interference fit. The method of manufacturing the sealed contact lens package may further comprise sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
  • The details of the contact lens or lenses, components of the solution, formulations, and all of the various other details as described U.S. patent application Ser. No. 14/109,976, filed Dec. 18, 2013 and entitled “Antimicrobial Ophthalmic Devices” are incorporated in their entirety by reference herein and form a part of the present application.
  • The following Examples illustrate certain aspects and advantages of the present invention, which should be understood not to be limited thereby.
  • Example 1 Contamination of Commercial Contact Lenses after Handling with Washed Hands
  • Commercially available balafilcon A contact lenses in their original blister packaging were used in this lens-handling study. Five individuals washed their hands with soap and water and dried their hands using paper towels. The foil cover of each blister was opened aseptically with a gloved hand by the investigator. Each individual removed and gently rubbed the lens for approximately 5 seconds using the same hand used to turn off the faucet. Each rubbed lens was then placed into an individual sterile 2 mL microcentrifuge (Eppendorf™) tube with 1 mL PBS-T and capped. As used herein, PBS refers phosphate buffered saline of 0.78 wt. % NaCl, 0.05 wt. % sodium phosphate monobasic, and 0.36 wt. % sodium phosphate dibasic at pH 7.5. PBS-T refers to PBS with 0.05% Polysorbate 80.
  • To extract any bacteria from the handled lenses, the tubes were sonicated for 3 cycles of 30 seconds each with 10 seconds vortexing in between. After the final sonication the tubes were vortexed for 10 minutes at 1000 rpm using a multi-tube vortexer. The entire volume of extract from each tube was plated onto a blood agar plate, allowed to dry in a biochemical hood, and incubated at 37° C. for 48-72 hours. Bacteria were counted and reported as CFU/lens. Each bacterium with a distinct phenotype was identified using a Biotyper.
  • Detectable levels of contamination from common skin bacteria (Staphylococcus epidermidis and Staphylococcus warneri) were found on all five balafilcon A contact lenses. The range of contamination was from 115-6500 CFU/lens. No lens was sterile. Although the identified bacteria are not commonly found in microbial keratitis, they can cause disease in immune-compromised patients.
  • To determine whether εPLL in a contact lens packaging solution would be protective immediately against microbes deposited during lens removal from a blister package, the above lens-handling study was repeated using ocufilcon D, comfilcon A, and omafilcon A contact lenses that had been individually packaged in a contact lens blister package containing a packaging solution of either PBS or PBS with 500 ppm εPLL, sealed with a foil cover, and autoclaved. All three lenses demonstrated a significant reduction in bioburden when εPLL was present in the packaging solution, with the following average log kill: ocufilcon D—2.4, comfilcon A—1.4, and omafilcon A—2.2.
  • Finally, we repeated the above lens-handling study to compare the contamination level of an ocufilcon D contact lens removed from a sealed autoclaved package containing PBS packaging solution with or without 500 ppm εPLL. We also determined the level of microbial contamination of ocufilcon D contact lenses that were removed from their sealed autoclaved packages containing PBS packaging solution. The lenses were removed from their packages aseptically using sterile forceps and placed into a well of a 24-well plate containing 1 ml of Optifree™ or AQuify™ brand contact lens solutions. Lenses exposed to ClearCare™ brand contact lens solutions were placed into the manufacturer-provided lens holder. After an overnight soak, the lenses (5 for each lens solution) were removed from the care solution using the above hand-washing, handling protocol and extracted as described above. As expected, the ClearCare™ contact lens solution, which does not contain any antimicrobial agents, did not provide protection against handling contamination. However, surprisingly, neither Optifree™ nor AQuify™ brand contact lens care solutions, both of which contain active antimicrobial agents, had any significant effect on bioburden. Only the solution containing PLL in the blister resulted in a statistically significant reduction in bacterial count (p=0.00002). The results are shown in Table 1.
  • TABLE 1
    Subject #
    Solution 1 2 3 4 5 Ave StDev P value
    PBS Log 2.3 2.8 2.4 3.0 2.8 2.7 0.27
    PBS + CFU/ 1.1 0.7 0 0.3 0.8 0.6 0.39 0.00002
    500 ppm Lens
    εPLL
    Optifree ™ 2.3 2.6 1.1 2.2 2.1 2.1 0.51 0.070
    AQuify ™ 2.4 2.7 2.9 3.0 3.3 2.9 0.30 0.348
    ClearCare ™ 0.5 2.5 2.3 2.8 .35 2.3 1.00 0.528
  • These experiments indicate that handling is a significant source of microbial contamination of conventional hydrogel and silicone hydrogel contact lenses. εPLL is protective against environmentally-derived bacteria deposited on the lens by lens handling. The carryover of εPLL from a packaging solution significantly reduced bioburden delivered by handling.
  • Example 2 Lens Handling Assay—Contamination of Contact Lenses from Pathogens Common in Microbial Keratitis
  • The bacterial adherence onto the surface of comfilcon A lenses removed from autoclaved blister packages containing a packaging solution of PBS with or without εPLL (10, 25, 100, or 500 ppm) was evaluated using a modification of methods described by Nomachi et al., Eye & Contact Lens (2013) 39:234-238. Briefly, the bacterial adherence onto the surface of comfilcon A contact lenses was evaluated using stock solutions of Pseudomona aeruginosa (PA) and Staphylococcus aureus (SA) prepared substantially as described in Example 3 below. Sterile surgical plastic gloves were put on both hands aseptically. After the seal of the comfilcon A package was opened, the thumb and index finger of a hand gloved were dipped into the bacterial suspension (approximately 103 CFU/ml in PBS) and used to remove a lens from a package. Four lenses of each type of packaging solution were tested. Each lens was placed into a microcentrifuge tube with 1 mL PBS-T, sonicated for 1.5 minute and vortexed for 10 minutes at 1000 rpm. The entire volume of the extract was plated onto a culture dish with tryptic soy agar (TSA) and grown at 37° C. for 2 days in an incubator.
  • Table 2 below shows the average CFU/Lens (n=4) on contact lenses removed from the different packaging solutions.
  • TABLE 2
    0 ppm 10 ppm 25 ppm 100 ppm 500 ppm
    Organism εPLL εPLL εPLL εPLL εPLL
    PA 54 42 16 1 0
    SA 43 37 35 21 7
  • After removal of the contact lenses by finger and thumb contaminated with PA, as described above, the blister package and remaining packaging solution were left covered with the original blister foil at ambient temperature. After 16 hours, the entire volume of remaining packaging solution (˜1 mL) was plated onto a culture dish with TSA and left in an incubator at 37° C. for 2 days to grow. The packaging solution without any added ePL had an average of 331 CFU/Lens. None of the ePL-containing packaging solutions exhibited microbial growth, i.e. all had 0 CFU/Lens.
  • Example 3 Preparation of Bacterial Suspensions
  • Cultures were prepared from growing a single colony of each of the bacterial species shown in Table 3 below in 50 mL. trypticase soy broth (TSB) overnight at 37° C. on a rotary shaker. 1 mL of each culture was centrifuged, and the bacterial pellet resuspended in 1.0 mL of the diluent shown in Table 3. For each bacterial species, a suspension of approximately 108 CFU/mL was prepared by diluting the bacterial suspension to achieve the optical density indicated in Table 3. Each suspension is further diluted for use in the handling assay described in Example 2 or the in vitro bioactivity assay described in Example 4.
  • TABLE 3
    Species Strain OD660 Media Diluent
    PA ATCC 99027 ~0.1 0.01% TSB in PBS-T
    SA ATCC 13880 ~0.3 10.0% TSB in PBS-T
  • Example 4 In Vitro Bioactivity Assay
  • A contact lens is removed from its packaging and rinsed in 2.5 ml sterile PBS for a few seconds to remove residual packaging solution. The rinsed lens is then transferred to an individual well of a 24-well plate containing 1.0 mL of 104 CFU PA. The plate is incubated at 37° C. with gentle shaking for 24 hours. The lens is removed from its well and transferred to a well of a 12-well plate containing 2.5 mL of sterile PBS. The plate is gently swirled for about 30 seconds. This step is repeated once for each lens.
  • Each washed lens is placed in a microcentrifuge tube containing 1 mL of Dey-Engley (DE) neutralizing broth and adhered bacteria are removed by a combination of sonication for about 2 minutes and vortexing for about 10 minutes. Serial dilutions are made for each recovered cell suspension using DE neutralizing broth and suitable dilutions are plated onto TSA. Plates are incubated overnight at 37° C. and CFUs are counted.
  • The CFU for each plate is multiplied by the dilution factor (DF) as well as the plating dilution factor (PDF). The total CFUs recovered for a given sample are then converted to the log 10. To calculate the log kill of a contact lens packaged in a packaging solution comprising εPLL (i.e. the “test lens”), the log of CFU/lens of the test lens is subtracted from that of a control lens, which is identical to the test lens and packaged in an identical package and contact lens packaging solution except that the packaging solution lacks the εPLL. For example, if the mean log 10 value of an antimicrobial lens is 1.05 and the mean log 10 value of an otherwise identical control lens lacking the active antimicrobial agent is 5.52, the log kill is 5.52−1.05=4.47.
  • Although the disclosure herein refers to certain illustrated examples, it is to be understood that these examples are presented by way of example and not by way of limitation. The intent of the foregoing detailed description, although discussing exemplary examples, is to be construed to cover all modifications, alternatives, and equivalents of the examples as may fall within the spirit and scope of the invention as defined by the additional disclosure.
  • A number of publications and patents have been cited hereinabove. Each of the cited publications and patents are hereby incorporated by reference in their entireties.
  • The present invention includes the following aspects/embodiments/features in any order and/or in any combination:
  • 1. A sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL), wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without εPLL.
    2. A sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL.
    3. The package of any preceding or following embodiment/feature/aspect wherein, in the test, the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
    4. The package of any preceding or following embodiment/feature/aspect, wherein, in the test, the unworn contact less results in less than a one log kill of PA (but more than a zero log kill) compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
    5. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a silicone hydrogel contact lens.
    6. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a non-ionic contact lens.
    7. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is an ionic contact lens.
    8. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a daily disposable contact lens.
    9. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens is a daily wear contact lens.
    10. The package of any preceding or following embodiment/feature/aspect, wherein the packaging solution comprises between 5 ppm and 500 ppm εPLL.
    11. The package of any preceding or following embodiment/feature/aspect, wherein the packaging solution comprises between 5 ppm and 50 ppm εPLL.
    12. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens package further comprises (a) a plastic base member comprising i) a cavity which retains the unworn contact lens and the contact lens packaging solution, and ii) a flange region extending outwardly around the cavity; and (b) a removable foil attached to the flange region.
    13. The package of any preceding or following embodiment/feature/aspect, wherein the contact lens package further comprises (a) a plastic base member comprising a cavity which retains the unworn contact lens and the contact lens packaging solution; and (b) a resealable cover that forms a liquid-tight seal with the plastic base member.
    14. The package of any preceding or following embodiment/feature/aspect, wherein the plastic base member comprises a plurality of threads for engagement with a compatible set of threads on the resealable cover.
    15. The package of any preceding or following embodiment/feature/aspect, wherein the at least one microbe is Pseudomonas aeruginosa.
    16. The package of any preceding or following embodiment/feature/aspect, wherein the at least one microbe is Staphylococcus aureus.
    17. The package of any preceding or following embodiment/feature/aspect, wherein the at least one microbe is a microbe found in microbial keratitis.
    18. A method of manufacturing the sealed contact lens package, said method comprising placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
    19. A method of manufacturing the sealed contact lens package, said method comprising placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
    20. The method of any preceding or following embodiment/feature/aspect, wherein the contact lens package is any one embodiments described above (e.g., 1 through 17.)
    21. The method of any preceding or following embodiment/feature/aspect further comprising sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
    22. A method of manufacturing the sealed contact lens package, said method comprising placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in a substantially identical contact lens packaging solution without εPLL, and wherein the contact lens package comprises a resealable cover.
    23. A method of manufacturing the sealed contact lens package, said method comprising placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the contact lens package comprises a resealable cover.
    24. The method of any preceding or following embodiment/feature/aspect, wherein the contact lens package is any one of 1 through 17.
    25. The method of any preceding or following embodiment/feature/aspect, further comprising sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
  • The present invention can include any combination of these various features or embodiments above and/or below as set forth in sentences and/or paragraphs. Any combination of disclosed features herein is considered part of the present invention and no limitation is intended with respect to combinable features.
  • Applicants specifically incorporate the entire contents of all cited references in this disclosure. Further, when an amount, concentration, or other value or parameter is given as either a range, preferred range, or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. Where a range of numerical values is recited herein, unless otherwise stated, the range is intended to include the endpoints thereof, and all integers and fractions within the range. It is not intended that the scope of the invention be limited to the specific values recited when defining a range.
  • Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the present specification and practice of the present invention disclosed herein. It is intended that the present specification and examples be considered as exemplary only with a true scope and spirit of the invention being indicated by the following claims and equivalents thereof.

Claims (17)

What is claimed is:
1. A sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay.
2. The package of claim 1, wherein the contact lens is a silicone hydrogel contact lens.
3. The package of claim 1, wherein the contact lens is a non-ionic contact lens.
4. The package of claim 1, wherein the contact lens is a daily disposable contact lens.
5. The package of claim 1, wherein the sealed contact lens package comprises a plastic base member that comprises a cavity and a flange region extending outwardly around the cavity, and a removable foil attached to the flange region.
6. The package of claim 1, wherein the packaging solution comprises between 5 ppm and 500 ppm εPLL.
7. A sealed contact lens package comprising:
a) a plastic base member comprising a cavity which retains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL); and
b) a resealable cover that forms a liquid-tight seal with the plastic base member, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL.
8. The package of claim 7, wherein the contact lens is a silicone hydrogel contact lens.
9. The package of claim 7, wherein the contact lens is an ionic contact lens.
10. The package of claim 7, wherein the contact lens is a daily wear contact lens.
11. The package of claim 7, wherein the plastic base member comprises a plurality of threads for engagement with a compatible set of threads on the resealable cover.
12. The package of claim 7, wherein the packaging solution comprises between 5 ppm and 500 ppm εPLL.
13. The package of claim 1, wherein the at least one microbe is Pseudomonas aeruginosa.
14. The package of claim 1, wherein the at least one microbe is Staphylococcus aureus.
15. The package of claim 1, wherein the at least one microbe is a microbe found in microbial keratitis.
16. A method of manufacturing the sealed contact lens package, said method comprising: placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where Pseudomonas aeruginosa (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 104 CFU PA using an in vitro bioactivity assay and/or wherein the contact lens package comprises a resealable cover.
17. The method of claim 16, further comprising sterilizing the unworn contact lens by autoclaving the sealed contact lens package.
US14/719,341 2014-06-19 2015-05-22 Protection of Contact Lenses from Microbial Contamination Caused by Handling Abandoned US20150366311A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022271958A1 (en) * 2021-06-23 2022-12-29 Performance Vision Technologies, Inc. Activity specific contact lenses

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3977517A (en) * 1974-07-22 1976-08-31 Bausch & Lomb Incorporated Contact lens carrying case
WO1994013774A1 (en) * 1992-12-09 1994-06-23 Allergan, Inc. Cleaning compositions and method for hydrophilic contact lenses
US5375698A (en) * 1993-05-07 1994-12-27 Allergan, Inc. Prefilled, resealable contact lens container
US6187264B1 (en) * 1996-02-02 2001-02-13 Asahi Kasei Kogyo Kabushiki Kaisha Solution for preserving and sterilizing contact lenses
US20070149428A1 (en) * 2005-12-14 2007-06-28 Bausch & Lomb Incorporated Method of Packaging a Lens
US20090236239A1 (en) * 2008-03-21 2009-09-24 Menicon Co., Ltd. Soft contact lens package product and method of packaging soft contact lens
US20100010452A1 (en) * 2007-01-09 2010-01-14 Fovea Pharmaceuticals Apparatus for intra-ocular injection
US20100104528A1 (en) * 2008-10-28 2010-04-29 Zora Marlowe Contact Lens Solution With a Tertiary Amine Oxide
US20140179825A1 (en) * 2012-12-21 2014-06-26 Coopervision International Holding Company, Lp Methods Of Manufacturing Contact Lenses For Delivery Of Beneficial Agents
US20140183063A1 (en) * 2012-12-21 2014-07-03 Novartis Ag Contact Lens Package

Family Cites Families (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US104528A (en) * 1870-06-21 Improvement in paddle-wheels
JPS5296953A (en) * 1976-02-10 1977-08-15 Nippon Steel Corp Method of grinding reinforcement roll for fourrstage rolling machine
US4168112A (en) 1978-01-05 1979-09-18 Polymer Technology Corporation Contact lens with a hydrophilic, polyelectrolyte complex coating and method for forming same
FR2542463A1 (en) * 1983-03-10 1984-09-14 Wepierre Isabelle Device for packaging physiological solutions for the care (upkeep) of contact lenses
DE4408394C2 (en) * 1994-03-12 1999-06-24 Bernd Hansen Packaging for contact lenses, in particular disposable contact lenses
CN2401065Y (en) * 1999-08-25 2000-10-18 北京优视隐形眼镜有限公司 Box for contact lens
DE29916848U1 (en) * 1999-09-24 1999-12-09 Woehlk Contact Linsen Gmbh Blister cover
JP2001228444A (en) * 2000-02-18 2001-08-24 Chisso Corp Cleaning and disinfecting solution for contact lens
JP2001264707A (en) * 2000-03-22 2001-09-26 Chisso Corp Disinfecting and preserving solution for contact lens
CA2426045A1 (en) 2000-10-24 2002-05-02 Bausch & Lomb Incorporated Prevention of bacterial attachment to biomaterials by cationic polysaccharides
US7402318B2 (en) 2001-11-14 2008-07-22 Novartis Ag Medical devices having antimicrobial coatings thereon
CN1498354A (en) * 2002-02-07 2004-05-19 欧得士株式会社 Contact lens solution
US8172395B2 (en) 2002-12-03 2012-05-08 Novartis Ag Medical devices having antimicrobial coatings thereon
US7282214B2 (en) 2002-12-19 2007-10-16 Johnson & Johnson Vision Care, Inc. Biomedical devices with antimicrobial coatings
US6868963B2 (en) * 2003-01-22 2005-03-22 Simcha Borovsky Contact lens cleaning and storage case with contaminant separation
JP3813133B2 (en) * 2003-04-16 2006-08-23 旭化成アイミー株式会社 Contact lens solution
US7416737B2 (en) * 2003-11-18 2008-08-26 Johnson & Johnson Vision Care, Inc. Antimicrobial lenses, processes to prepare them and methods of their use
US20050205451A1 (en) * 2004-03-18 2005-09-22 Brown-Skrobot Susan K Contact lens packages
JP2006201247A (en) * 2005-01-18 2006-08-03 Taki Chem Co Ltd Sterilizing storage solution for contact lens
US7426993B2 (en) 2005-08-09 2008-09-23 Coopervision International Holding Company, Lp Contact lens package
DK1976570T3 (en) * 2006-01-18 2019-07-29 Menicon Singapore Pte Ltd Methods and systems for sterilizing contact lenses
EP2043476B1 (en) * 2006-07-14 2012-03-28 Johnson and Johnson Vision Care, Inc. Screw cap package for contact lens
US7477366B2 (en) * 2006-12-07 2009-01-13 Coopervision International Holding Company, Lp Contact lens blister packages and methods for automated inspection of hydrated contact lenses
US8689971B2 (en) * 2007-08-31 2014-04-08 Novartis Ag Contact lens packaging solutions
US8349303B1 (en) * 2009-04-29 2013-01-08 Bausch & Lomb Incorporated Polymeric quaternium compounds
JP5247597B2 (en) 2009-06-03 2013-07-24 株式会社シード Wettable hydrogel contact lens and manufacturing method thereof
EP2452212B1 (en) * 2009-07-09 2015-03-25 Bausch & Lomb Incorporated Mono ethylenically unsaturated polymerizable group containing polycarbosiloxane monomers
TWI492769B (en) 2009-09-23 2015-07-21 Alcon Res Ltd Injectable aqueous ophthalmic composition and method of use therefor
US20110284764A1 (en) * 2010-05-19 2011-11-24 Pugh Randall B Ophthalmic lens disinfecting base
JP2011245053A (en) * 2010-05-27 2011-12-08 Nanyang Technological Univ Polymerizable composition for ophthalmic and medical use and antibacterial composition obtained by polymerizing the same
JP5613779B2 (en) * 2011-01-19 2014-10-29 株式会社メニコン Contact lens solution
WO2014091574A1 (en) * 2012-12-12 2014-06-19 株式会社メニコン Disinfectant solution for nonionic soft contact lenses
US20140178327A1 (en) * 2012-12-21 2014-06-26 Coopervision International Holding Company, Lp Antimicrobial Ophthalmic Devices
US9161598B2 (en) * 2012-12-21 2015-10-20 Coopervision International Holding Company, Lp Ophthalmic devices for delivery of beneficial agents

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3977517A (en) * 1974-07-22 1976-08-31 Bausch & Lomb Incorporated Contact lens carrying case
WO1994013774A1 (en) * 1992-12-09 1994-06-23 Allergan, Inc. Cleaning compositions and method for hydrophilic contact lenses
US5375698A (en) * 1993-05-07 1994-12-27 Allergan, Inc. Prefilled, resealable contact lens container
US6187264B1 (en) * 1996-02-02 2001-02-13 Asahi Kasei Kogyo Kabushiki Kaisha Solution for preserving and sterilizing contact lenses
US20070149428A1 (en) * 2005-12-14 2007-06-28 Bausch & Lomb Incorporated Method of Packaging a Lens
US20100010452A1 (en) * 2007-01-09 2010-01-14 Fovea Pharmaceuticals Apparatus for intra-ocular injection
US20090236239A1 (en) * 2008-03-21 2009-09-24 Menicon Co., Ltd. Soft contact lens package product and method of packaging soft contact lens
US20100104528A1 (en) * 2008-10-28 2010-04-29 Zora Marlowe Contact Lens Solution With a Tertiary Amine Oxide
US20140179825A1 (en) * 2012-12-21 2014-06-26 Coopervision International Holding Company, Lp Methods Of Manufacturing Contact Lenses For Delivery Of Beneficial Agents
US20140183063A1 (en) * 2012-12-21 2014-07-03 Novartis Ag Contact Lens Package

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022271958A1 (en) * 2021-06-23 2022-12-29 Performance Vision Technologies, Inc. Activity specific contact lenses

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