Methods of using and screening extended wear ophthalmic lenses

• US 5,776,999 A
• Filed: 07/17/1996
• Issued: 07/07/1998
• Est. Priority Date: 09/06/1994
• Status: Expired due to Term

• Current Assignee: Novartis Ag
• Original Assignee: CIBA Vision Corporation (Bayer AG)
• Inventors: Court, John, Winterton, Lynn Cook, Ho, Arthur, Lohmann, Dieter, Chabrecek, Peter, Liu, Qin, Riffle, Judy Smith, Papaspiliotopoulos, Eric, Meijs, Gordon Francis, Schindhelm, Klaus, Laycock, Bronwyn Glenice, Domschke, Angelika, Nicolson, Paul Clement, Baron, Richard Carlton, Sweeney, Deborah, Terry, Wilson Leonard Jr., Hopken, Jens, Griesser, Hans Jorg, Vogt, Jurgen
• Primary Examiner(s): MERRIAM, ANDREW EDWIN
• Application Number:
  US08/682,496
• Time in Patent Office: 720 Days
• Field of Search: 454/449, 351/247, 264/2.6, 264/1.36, 523/106, 523/107, 523/903
• US Class Current: 523/106
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: B05D 1/62 Plasma-deposition of organic layers plasma deposition in general C23C14/00, C23C16/00
• CPC Class Codes: B29C 39/42 Casting under special conditions, e.g. vacuum
• CPC Class Codes: B29C 71/00 After-treatment of articles without altering their shape; Apparatus therefor B29C44/56, B29C73/00 take precedence; surface shaping B29C59/00 ; for joined or sealed parts B29C66/03; after-treatment specially adapted for vulcanising tyres B29D30/0633
• CPC Class Codes: B29D 11/00076 enabling passage of fluids, e.g. oxygen, tears, between the area under the lens and the lens exterior
• CPC Class Codes: B29L 2011/0041 Contact lenses
• CPC Class Codes: C08G 18/10 Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step
• CPC Class Codes: C08G 18/48 Polyethers
• CPC Class Codes: C08G 18/4833 Polyethers containing oxyethylene units
• CPC Class Codes: C08G 18/5015 having fluorine atoms
• CPC Class Codes: C08G 18/61 Polysiloxanes
• CPC Class Codes: C08G 18/63 Block or graft polymers obtained by polymerising compounds having carbon-to-carbon double bonds on to polymers
• CPC Class Codes: C08G 18/672 Esters of acrylic or alkyl acrylic acid having only one group containing active hydrogen
• CPC Class Codes: C08G 18/8116 esters of acrylic or alkylacrylic acid having only one isocyanate or isothiocyanate group
• CPC Class Codes: C08G 18/8175 with esters of acrylic or alkylacrylic acid having only one group containing active hydrogen
• CPC Class Codes: C08L 33/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 51/08 grafted on to macromolecular compounds obtained otherwise than by reactions only involving unsaturated carbon-to-carbon bonds
• CPC Class Codes: C08L 51/085 on to polysiloxanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: G02B 1/043 : Contact lenses
• CPC Class Codes: Y10S 525/903 : Interpenetrating network
• CPC Class Codes: Y10S 525/936 : Encapsulated chemical agent
• CPC Class Codes: Y10S 525/937 : Utility as body contact e.g. implant, contact lens or I.U.D.

Abstract

An ophthalmic lens screening method suited for extended-wear for periods of at least one day on the eye without a clinically significant amount of corneal swelling and without substantial wearer discomfort. The lens has a balance of oxygen permeability and ion or water permeability, with the ion or water permeability being sufficient to provide good on-eye movement, such that a good tear exchange occurs between the lens and the eye. A preferred lens is a copolymerization product of a oxyperm macromer and an ionoperm monomer. The invention encompasses extended wear contact lenses, which include a core having oxygen transmission and ion transmission pathways extending from the inner surface to the outer surface.

Claims

1. A method of using a contact lens as an extended wear lens, said lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high water permeability, said polymeric material being formed from polymerizable materials including:

(a) at least one oxyperm polymerizable material; and

(b) at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone, would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2×

10^-6 cm² /sec or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5×

10^-6 mm² /min, wherein said ion permeability is measured with respect to sodium ions,

said method comprising the steps of;

(a) applying said lens to the ocular environment; and

(b) allowing said lens to remain in intimate contact with the ocular environment for a first period of at least 24 hours.

2. A method of claim 1, further including the steps of:

(c) removing said lens from the ocular environment;

(d) disinfecting or cleaning said lens;

(e) re-applying said lens to the ocular environment; and

(f) allowing said lens to remain in intimate contact with the ocular environment for a second period of at least 24 hours.

3. A method of claim 1, wherein said first intimate contact period is at least 4 days.

4. A method of claim 2, wherein said first and second intimate contact periods are at least 4 days.

5. A method of claim 3, wherein said first intimate contact period is at least 7 days.

6. A method of claim 4, wherein said first and second intimate contact periods are at least 7 days.

7. A method of claim 5, wherein said first intimate contact period is at least 14 days.

8. A method of claim 6, wherein said first and second intimate contact periods are at least 14 days.

9. A method of claim 7, wherein said first intimate contact period is at least 30 days.

10. A method of claim 8, wherein said first and second intimate contact periods are at least 30 days.

11. An ophthalmic lens of claim 1, wherein said lens produces, after wear of about 24 hours, including normal sleep periods, less than about 8% corneal swelling.

12. An ophthalmic lens of claim 11, wherein said lens produces, after wear of about 24 hours, including normal sleep periods, less than about 6% corneal swelling.

13. An ophthalmic lens of claim 12, wherein said lens produces, after wear of about 24 hours, including normal sleep periods, less than about 4% corneal swelling.

14. An ophthalmic lens of claim 1, wherein said lens produces, after wear of about 7 days, including normal sleep periods, less than about 10% corneal swelling.

15. An ophthalmic lens of claim 14, wherein said lens produces, after wear of about 7 days, including normal sleep periods, less than about 7% corneal swelling.

16. An ophthalmic lens of claim 15, wherein said lens produces, after wear of about 7 days, including normal sleep periods, less than about 5% corneal swelling.

17. A method of screening an ophthalmic lens for utility as an extended-wear lens, said method comprising the steps of:

(a) allowing said lens to be fully hydrated by allowing said lens to equilibrate in a saline solution;

(b) testing the lens to determine a factor which is a function of the oxygen transmissibility of said lens;

(c) testing the lens to determine a factor which is a function of the ion or water permeability of said lens; and

(d) selecting said lens as an extended-wear lens if said oxygen transmissibility factor and said water or ion permeability factor are both above predetermined limits which are established to ensure good corneal health and wearer comfort when said lens is in intimate contact with a human eye for a period of continuous, extended wear of at least 24 hours, said ion or water permeability limits being at least either (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2×

10^-6 cm² /sec or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5×

10^-6 mm² /min, as measured with respect to sodium ions,

thereby ensuring said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a said extended wear.

18. A screening method of claim 17, wherein said ion permeability factor is the Ionoton Ion Permeability Coefficient.

19. A screening method of claim 18, wherein said Ionoton Ion Permeability Coefficient is greater than about 0.3×

10^-6 cm² /sec, wherein said Ionoton Ion Permeability Coefficient is measured with respect to sodium ions.

20. A screening method of claim 17, wherein said ion permeability factor is the Ionoflux Diffusion Coefficient.

21. A screening method of claim 20, wherein said Ionoflux Diffusion Coefficient is greater than about 2.6×

10^-6 mm² /min, wherein said Ionoflux Ion Permeability Coefficient is measured with respect to sodium ions.

22. A screening method of claim 17, wherein said water permeability factor is the Hydrodell Water Permeability Coefficient.

23. A screening method of claim 22, wherein said Hydrodell Water Permeability Coefficient is greater than about 0.3×

10^-6 cm² /sec.

24. A screening method of claim 19, wherein said oxygen transmissibility factor is the Dk and the limit is 70 barrers/mm.

25. A screening method of claim 21, wherein said oxygen transmissibility factor is the Dk and the limit is 70 barrers/mm.

26. A screening method of claim 23, wherein said oxygen transmissibility factor is the Dk and the limit is 70 barrers/mm.