Extended wear ophthalmic lens
DCFirst Claim
1. A method for producing an extended wear contact lens, said contact lens comprising a core polymeric material which has a high oxygen permeability and a high ion or water permeability, which method comprises the steps of:
- a) preparing a lens formulation comprising an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and flourine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
b) placing said lens formulation in a lens mold;
c) polymerizing- said lens formulation in said mold to form a lens core material having inner and outer surfaces such that said oxyperm polymerizable material and said ionoperm polymerizable material of said lens formulation form separate oxyperm and ionoperm phases;
said lens core material having an oxygen permeability equal to or greater than 77 barrers;
d) removing said lens core material from said lens mold;
e) subjecting said lens core material to a treatment to modify said surfaces of said lens core material, wherein the surface treatment makes said surfaces more biocompatible with the ocular tissue and ocular fluids than said core material alone; and
f) hydrating the treated lens core material to produce a hydrated extended wear contact lens, wherein the modified surfaces of said lens in conjunction with the high oxygen and ion permeabilities of said core polymeric material allows said hydrated lens to be worn as extended wear lens that is worn for a continuous period of at least 24 hours with corneal swelling of less than about 8%.
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Abstract
An ophthalmic lens suited for extended-wear 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.
368 Citations
84 Claims
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1. A method for producing an extended wear contact lens, said contact lens comprising a core polymeric material which has a high oxygen permeability and a high ion or water permeability, which method comprises the steps of:
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a) preparing a lens formulation comprising an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and flourine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
b) placing said lens formulation in a lens mold;
c) polymerizing- said lens formulation in said mold to form a lens core material having inner and outer surfaces such that said oxyperm polymerizable material and said ionoperm polymerizable material of said lens formulation form separate oxyperm and ionoperm phases;
said lens core material having an oxygen permeability equal to or greater than 77 barrers;
d) removing said lens core material from said lens mold;
e) subjecting said lens core material to a treatment to modify said surfaces of said lens core material, wherein the surface treatment makes said surfaces more biocompatible with the ocular tissue and ocular fluids than said core material alone; and
f) hydrating the treated lens core material to produce a hydrated extended wear contact lens, wherein the modified surfaces of said lens in conjunction with the high oxygen and ion permeabilities of said core polymeric material allows said hydrated lens to be worn as extended wear lens that is worn for a continuous period of at least 24 hours with corneal swelling of less than about 8%. - View Dependent Claims (2, 3, 4)
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5. An extended wear contact lens comprising a core polymeric material and upper and lower surfaces, said core polymeric material comprising a silicone copolymer which provides a high ion permeability and a high oxygen permeability;
- wherein said silicone copolymer comprises an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and fluorine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones;
said core polymeric material having an oxygen permeability equal to or greater than 77 barrers;
wherein said surfaces are hydrophilically modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes; and
wherein said extended wear contact lens can be continuously worn for at least four days on a human eye without substantial corneal swelling. - View Dependent Claims (6, 7, 8, 9)
- wherein said silicone copolymer comprises an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and fluorine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones;
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10. A hydrogel contact lens having modified surfaces, said hydrogel contact lens comprising a core polymeric material having an oxygen permeability equal to or greater than 77 barrers, said hydrogel contact lens being suited to make contact with ocular tissue and ocular fluids and having a high oxygen permeability and a high ion permeability, said core polymeric material having formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and fluorine-containing monomers, and (b) an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said lens has a high oxygen permeability and allows ion or water permeation 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 continuous contact with ocular tissue and ocular fluids, wherein said lens has an oxygen permeability of at least about 77 barrers and an ion permeability characterized either by an Ionoflux Ion Diffusion Coefficient of grater than about 6.4×
10-6 mm2/sec or an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/min,wherein said modified surfaces are hydrophilically modified surfaces that are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes, wherein said hydrogel contact lens is adapted for at least 24 hours of continuous wear on a human eye without substantial corneal swelling. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A method of using a contact lens as an extended wear lens, said lens having ophthalmically compatible modified 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 ion or water permeability, and which has an oxygen permeability equal to or greater than 77 barrers, said polymeric material being formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material selected from the group consisting of fluorine-containing macromers and fluorine-containing monomers, and (b) an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said modified surfaces are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes;
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 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; and
wherein said ophthalmic lens has an oxygen permeability of at least about 70 barrers and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/sec or (2) an Ionoflux Diffusion Coefficient of greater than about 6.4×
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 period of at least 24 hours. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24)
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25. A method for producing an extended wear contact lens, said contact lens comprising a core polymeric material which has a high oxygen permeability and a high ion or water permeability, which method comprises the steps of:
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a) preparing a lens formulation comprising an oxyperm polymerizable material, and an ionoperm polymerizable material, wherein said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
b) placing said lens formulation in a lens mold;
c) polymerizing said lens formulation in said mold to form a lens core material having inner and outer surfaces such that said oxyperm polymerizable material and said ionoperm polymerizable material of said lens formulation form separate oxyperm and ionoperm phases;
said lens core material having an oxygen permeability equal to or greater than 69 barrers;
d) removing said lens core material from said lens mold;
e) subjecting said lens core material to a treatment to modify said surfaces of said lens core material, wherein the surface treatment makes said surfaces more hydrophilic or lipophobic and more biocompatible with the ocular tissue than said core material alone; and
f) hydrating the treated lens core material to produce a hydrated extended wear contact lens, wherein the modified surfaces of said lens in conjunction with the high oxygen and ion permeabilities of said core polymeric material allows said hydrated lens to be worn as extended wear lens that is worn for a continuous period of at least 24 hours without having substantial amounts of lipid adsorption. - View Dependent Claims (26, 27, 28)
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29. An-extended wear contact lens comprising a core polymeric material and upper and lower surfaces, said core polymeric material comprising a silicone copolymer which provides a high ion permeability and a high oxygen permeability;
- said silicone copolymer comprising an oxyperm polymerizable material, and an ionoperm polymerizable material;
said core polymeric material having an oxygen permeability equal to or greater than 69 barrers;
wherein said surfaces are hydrophilically modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes; and
wherein said extended wear contact lens can be continuously worn for at least four days on a human eye without substantial corneal swelling and without having substantial amounts of lipid adsorption. - View Dependent Claims (30, 31, 32, 33)
- said silicone copolymer comprising an oxyperm polymerizable material, and an ionoperm polymerizable material;
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34. A siloxane hydrogel contact lens having modified surfaces, said hydrogel contact lens comprising a core polymeric material having an oxygen permeability equal to or greater than 69 barrers, said hydrogel contact lens being suited to make contact with ocular tissue and ocular fluids and having a high oxygen permeability and a high ion permeability, said core polymeric material being formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material, and (b) an ionoperm polymerizable material, wherein said lens has a high oxygen permeability and allows ion or water permeation 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 continuous contact with ocular tissue and ocular fluids, wherein said lens has an oxygen permeability of at least about 69 barrers and an ion permeability characterized either by an Ionoflux Ion Diffusion Coefficient of greater than about 6.4×
10-6 mm2/sec or an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/min,wherein said modified surfaces are hydrophilically modified surfaces that are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes, wherein said hydrogel contact lens is adapted for at least 24 hours of continuous wear on a human eye without substantial corneal swelling and without having substantial amounts of lipid adsorption. - View Dependent Claims (35, 36, 37, 38, 39, 40)
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41. A method of using a contact lens as an extended wear lens, said lens having ophthalmically compatible modified 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 ion or water permeability, and which has an oxygen permeability equal to or greater than 69 barrers, said polymeric material being formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material, and (b) an ionoperm polymerizable material, wherein said modified surfaces are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes;
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 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 without having substantial amounts of lipid absorption; and
wherein said ophthalmic lens has an oxygen permeability of at least about 70 barrers and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/sec or (2) an Ionoflux Diffusion Coefficient of greater than about 6.4×
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 continuous intimate contact with the ocular environment for a period of at least 24 hours without having substantial amounts of lipid adsorption. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48)
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49. A method of forming a biocompatible lens having high oxygen permeability and high water permeability, said method comprising the steps of:
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(a) forming a polymeric core formulation comprising an oxyperm polymerizable material, and an ionoperm polymerizable material, said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
(b) polymerizing the core in an atmosphere substantially free from oxygen;
(c) altering the surface of said core material to produce a surface which is more hydrophilic than said core material; and
(d) autoclaving lens at predetermined temperatures;
whereby 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, and whereby said lens allows ion permeation 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 lens having adequate movement on the eye with blinking to promote adequate tear exchange and without producing significant corneal swelling, without having substantial amounts of lipid adsorption, and without causing substantial wearer discomfort during the period of contact for at least 24 hours, 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) by an Ionoflux Ion Permeability Coefficient of greater than about 1.5×
10−
6 mm2/min, wherein said ion permeability is measured with respect to sodium ions.
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50. A method of forming a contact lens having high oxygen permeability and high water permeability, said method comprising:
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(a) forming a polymeric core material in the shape of a contact lens having an inner and outer surface; and
(b) altering the surfaces of said core material to produce new surfaces that are more hydrophilic than said core material, wherein said lens having adequate movement on the eye with blinking to promote adequate tear exchange and without producing significant corneal swelling, without having substantial amounts of lipid adsorption, and without causing substantial wearer discomfort during the period of contact for at least 24 hours. - View Dependent Claims (51, 52, 53)
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54. A biocompatible contact lens having high oxygen permeability and high water permeability, said lens comprising:
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(a) a polymeric core material in the shape of a contact lens having an inner and outer surface; and
(b) said surfaces of said core material being surface modified to produce new surfaces that are more hydrophilic than said core material, wherein said lens having adequate movement on the eye with blinking to promote adequate tear exchange and without producing significant corneal swelling, without having substantial amounts of lipid adsorption, and without causing substantial wearer discomfort during the period of contact for at least 24 hours. - View Dependent Claims (55, 56, 57, 58, 59)
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60. A method for producing an extended wear contact lens, said contact lens comprising a core polymeric material which has a high oxygen permeability and a high ion or water permeability, which method comprises the steps of:
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a) preparing a lens formulation comprising an oxyperm polymerizable material, and an ionoperm polymerizable material, wherein said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
b) placing said lens formulation in a lens mold;
c) polymerizing said lens formulation in said mold to form a lens core material having inner and outer surfaces such that said oxyperm polymerizable material and said ionoperm polymerizable material of said lens formulation form separate oxyperm and ionoperm phases;
said lens core material having an oxygen permeability equal to or greater than 69 barrers;
d) removing said lens core material from said lens mold;
e) subjecting said lens core material to a treatment to modify said surfaces of said lens core material, wherein the surface treatment makes said surfaces more hydrophilic or lipophobic and more biocompatible with the ocular tissue than said core material alone; and
f) hydrating the treated lens core material to produce a hydrated extended wear contact lens, wherein the modified surfaces of said lens in conjunction with the high oxygen and ion permeabilities of said core polymeric material allows said hydrated lens to be worn as extended wear lens that is worn for a continuous period of at least 24 hours without having substantial amounts of lipid adsorption.
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61. A method for producing an extended wear contact lens, said contact lens comprising a core polymeric material which has a high oxygen permeability and a high ion or water permeability, which method comprises the steps of:
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a) preparing a lens formulation comprising an oxyperm polymerizable material selected from the group consisting of siloxane-containing macromers, fluorine-containing macromers and fluorine monomers, and an ionoperm polymerizable material, wherein said oxyperm polymerizable material comprises between about 30% to about 70%, based on the total weight, of said lens formulation;
b) placing said lens formulation in a lens mold;
c) polymerizing said tens formulation in said mold to form a lens core material having inner and outer surfaces such that said oxyperm polymerizable material and said ionoperm polymerizable material of said lens formulation form separate oxyperm and ionoperm phases;
said lens core material having at least one continous pathway from said inner surface to said outer surface for oxygen transmission therethrough;
d) removing said lens core material from said lens mold;
e) subjecting said lens core material to a treatment to modify said surfaces of said lens core material, wherein the surface treatment makes said surfaces more hydrophilic or lipophobic and more biocompatible with the ocular tissue than said core material alone; and
f) hydrating the treated lens core material to produce a hydrated extended wear contact lens, wherein the modified surfaces of said lens in conjunction with the high oxygen and ion permeabilities of said core polymeric material allows said hydrated lens to be worn as extended wear lens that is worn for a continuous period of at least 24 hours with corneal swelling of less than about 8%. - View Dependent Claims (62, 63, 64)
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65. An extended wear contact lens comprising a core polymeric material and upper and lower surfaces, said core polymeric material comprising a silicone copolymer which provides a high ion permeability and a high oxygen permeability;
- wherein said silicone copolymer comprises an oxyperm polymerizable material selected from the group consisting of siloxane-containing macromers, siloxane-containing monomers, fluorine- containing macromers, siloxane containing monomers and fluorine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said core polymeric material has at least one continuous pathway from said upper surface to said lower surface for oxygen transmission;
wherein said surfaces are hydrophilically modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes; and
wherein said extended wear contact lens can be continuously worn for at least four days on a human eye without substantial corneal swelling. - View Dependent Claims (66, 67, 68, 69)
- wherein said silicone copolymer comprises an oxyperm polymerizable material selected from the group consisting of siloxane-containing macromers, siloxane-containing monomers, fluorine- containing macromers, siloxane containing monomers and fluorine-containing monomers, and an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said core polymeric material has at least one continuous pathway from said upper surface to said lower surface for oxygen transmission;
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70. A hydrogel contact lens having modified surfaces, said hydrogel contact lens comprising a core polymeric material having at least one continuous pathway between said surfaces for oxygen transmission therethrough, said hydrogel contact lens being suited to make contact with ocular tissue and ocular fluids and having a high oxygen permeability and a high ion permeability, said core polymeric material having formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material selected from the group consisting of siloxane-containing macromers, siloxane-containing monomers, fluorine-containing macromers and fluorine-containing monomers, and (b) an ionoperm polymerizable material selected from the group consisting of acrylates, methacrylates, polyalkylene glycols and N-vinyl pyrrolidones, wherein said lens has a high oxygen permeability and allows ion or water permeation 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 continuous contact with ocular tissue and ocular fluids, wherein said lens has an oxygen permeability of at least about 70 barrers and an ion permeability characterized either by an Ionoflux Ion Diffusion Coefficient of grater than about 6.4×
10-6 mm2/sec or an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/min,wherein said modified surfaces are hydrophilically modified surfaces that are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes, wherein said hydrogel contact lens is adapted for at least 24 hours of continuous wear on a human eye without substantial corneal swelling. - View Dependent Claims (71, 72, 73, 74, 75, 76)
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77. A method of using a contact lens as an extended wear lens, said lens having ophthalmically compatible modified 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 ion or water permeability, and which has at least one continous pathway between said modified surfaces for oxygen surfaces, said polymeric material being formed from polymerizable materials comprising:
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(a) an oxyperm polymerizable material, and (b) an ionoperm polymerizable material, wherein said modified surfaces are modified by a treatment process selected from the group consisting of coating processes, grafting processes, plasma treating processes, electrical charge treating processes and irradiation processes;
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 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 without having substantial amounts of lipid absorption; and
wherein said ophthalmic lens has an oxygen permeability of at least about 70 barrers and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.4×
10-6 cm2/sec or (2) an Ionoflux Diffusion Coefficient of greater than about 6.4×
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 continous intimate contact with the ocular environment for a period of at least 24 hours. - View Dependent Claims (78, 79, 80, 81, 82, 83, 84)
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Specification