Ophthalmic solutions and methods for improving the comfort and safety of contact lenses

Claim 2

An ophthalmic comfort drop solution for intra ocular use with a daily wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.1 to 0.5% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscosity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 50 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 0.5% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 3

The comfort drop of claim 1 wherein said flattening agent is urea.

Claim 4

The comfort drop of claim 1 wherein said flattening agent is present in an amount of 0.1% to 0.4% by weight.

Claim 5

The comfort drop of claim 1 wherein said flattening agent is present in an amount of 0.15% to 0.3% by weight.

Claim 6

An ophthalmic comfort drop solution for intra ocular use with a daily wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.1 to 0.5% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscocity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 20 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 1% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 7

An ophthalmic comfort drop solution for intra ocular use with a daily wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.1 to 0.5% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscocity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 20 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 1% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 8

The comfort drop of claim 5 wherein said Brookfield relative viscosity is in the range of from 6 to 11 cps.

Claim 9

The comfort drop of claim 1 wherein said viscosity enhancing agent is hydroxyethyl cellulose.

Claim 10

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.3% by weight sodium chloride.

Claim 11

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.5% by weight sodium chloride.

Claim 12

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.75% by weight sodium chloride.

Claim 13

The comfort drop of claim 1 wherein said ionic salt is sodium chloride.

Claim 14

The comfort drop of claim 1 wherein said preservative is ocularly non-irritating.

Claim 15

The comfort drop of claim 1 wherein said preservative is present in an amount of from 0.001 to 0.5% by weight of said comfort drop.

Claim 16

The comfort drop of claim 1 wherein said preservative is present in an amount of 0.1 to 0.25% by weight of said comfort drop.

Claim 17

The comfort drop of claim 1 wherein said preservative is sorbic acid.

Claim 18

The comfort drop of claim 1 wherein said pH of said comfort drop is from 7.0 to 7.6.

Claim 19

The comfort drop of claim 1 wherein said pH of said comfort drop is about 7.3.

Claim 20

The comfort drop of claim 1 wherein said buffer is a borate buffer.

Claim 21

The comfort drop of claim 1 consisting essentially of about 0.2% by weight urea; about 0.44% by weight NaCl; about 0.16% by weight Boric Acid; about 0.38% by weight Na tetraborate decahydrate; about 0.2% by weight disodium EDTA; about 0.15% by weight sorbic acid; about 0.7% by weight hydroxyethylcellulose; about 0.2% by weight Poloxamer 407; and water.

Claim 22

An ophthalmic comfort drop solution for intra ocular use with an extended wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.0005 to 0.1% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscosity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 50 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 0.5% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 23

An ophthalmic comfort drop solution for intra ocular use with an extended wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.0005 to 0.1% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscosity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 50 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 0.5% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 24

The comfort drop of claim 1 wherein said flattening agent is urea.

Claim 25

The comfort drop of claim 1 wherein said flattening agent is present in an amount of 0.001% to 0.08% by weight.

Claim 26

The comfort drop of claim 1 wherein said flattening agent is present in an amount of 0.01% to 0.05% by weight.

Claim 27

An ophthalmic comfort drop solution for intra ocular use with an extended wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.0005 to 0.1% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscosity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 20 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 1% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 28

An ophthalmic comfort drop solution for intra ocular use with an extended wear hydrogel contact lens so as to improve the exchange of (I) ocular fluid trapped between said lens and an eye to which said lens has been applied for (II) ocularly compatable fluid not so trapped, said solution consisting essentially of: (a) 0.0005 to 0.1% by weight of a lens flattening agent selected from urea, glycerin, sorbitol, aminoethanol and mixtures thereof; (b) an ocularly acceptable ionic salt in an amount sufficient to give the entire comfort drop solution a tonicity in the range of 270-330 milliosmoles per kilogram of said comfort drop solution; (c) an ocularly acceptable viscosity enhancing agent in an amount sufficient to give said comfort drop solution a Brookfield relative viscosity in the range of 3 to 20 cps; (d) an ocularly acceptable buffer in an amount of 0% or an effective buffering amount to result in said comfort drop solution having a pH of about 6.5 to about 8; (e) 0% to 0.5% of an ocularly acceptable preservative; (f) 0% to 2% of an ocularly acceptable lubricant; (g) 0% to an ocularly vasoconstricting effective amount of an ocular decongestant; (h) 0% to 1% of a non-ionic ocularly acceptable surfactant; and (i) water.

Claim 29

The comfort drop of claim 24 wherein said Brookfield relative viscosity is in the range of from 6 to 11 cps.

Claim 30

The comfort drop of claim 1 wherein said viscosity enhancing agent is hydroxyethyl cellulose.

Claim 31

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.3% by weight sodium chloride.

Claim 32

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.5% by weight sodium chloride.

Claim 33

The comfort drop of claim 1 wherein said ionic salt is present in at least an amount which is equivalent in osmolarity to a solution of 0.75% by weight sodium chloride.

Claim 34

The comfort drop of claim 1 wherein said ionic salt is sodium chloride.

Claim 35

The comfort drop of claim 1 wherein said preservative is ocularly non-irritating.

Claim 36

The comfort drop of claim 1 wherein said preservative is present in an amount of from 0.001 to 0.5% by weight of said comfort drop.

Claim 37

The comfort drop of claim 1 wherein said preservative is present in an amount of 0.1 to 0.25% by weight of said comfort drop.

Claim 38

The comfort drop of claim 1 wherein said preservative is sorbic acid.

Claim 39

The comfort drop of claim 1 wherein said pH of said comfort drop is from 7.0 to 7.6.

Claim 40

The comfort drop of claim 1 wherein said pH of said comfort drop is about 7.3.

Claim 41

The comfort drop of claim 1 wherein said buffer is a borate buffer.

Claim 42

The comfort drop of claim 1 consisting essentially of about 0.03% by weight urea; about 0.52% by weight NaCl; about 0.16% by weight Boric Acid; about 0.38% by weight Na tetraborate decahydrate; about 0.2% by weight disodium EDTA; about 0.15% by weight sorbic acid; about 0.7% by weight hydroxyethylcellulose; about 0.2% by weight Poloxamer 407; and water.

Claim 43

A method for improving the exchange of (I) fluid located between a daily wear hydrogel contact lens and an eye to which said lens has been applied, with (II) an ocularly compatible fluid not so located, while said lens is being worn on said eye comprising instilling to said eye, having said lens thereon, a fluid exchange improving effective amount of a comfort drop solution of claim 1, whereby said lens is temporarily flattened allowing for greater fluid exchange than is possible in the absence of said comfort drop solution of claim 1.

Claim 44

The method of claim 39 wherein said comfort drop is instilled in an amount of 1 to about 5 drops up to about 5 times daily.

Claim 45

A method for improving the exchange of (I) fluid located between a daily wear hydrogel contact lens and an eye to which said lens has been applied, with (II) an ocularly compatible fluid not so located, while said lens is being worn on said eye comprising instilling to said eye, having said lens thereon, a fluid exchange improving effective amount of a comfort drop solution of claim 19, whereby said lens is temporarily flattened allowing for greater fluid exchange than is possible in the absence of said comfort drop solution of claim 19.

Claim 46

The method of claim 41 wherein said comfort drop is instilled in an amount of 1 to about 5 drops up to about 5 times daily.

Claim 47

A method for improving the exchange of (I) fluid located between an extended wear hydrogel contact lens and an eye to which said lens has been applied, with (II) an ocularly compatible fluid not so located, while said lens is being worn on said eye comprising instilling to said eye, having said lens thereon, a fluid exchange improving effective amount of a comfort drop solution of claim 20, whereby said lens is temporarily flattened allowing for greater fluid exchange than is possible in the absence of said comfort drop solution of claim 20.

Claim 48

The method of claim 43 wherein said comfort drop is instilled in an amount of 1 to about 5 drops up to about 5 times daily.

Claim 49

A method for improving the exchange of (I) fluid located between an extended wear hydrogel contact lens and an eye to which said lens has been applied, with (II) an ocularly compatible fluid not so located, while said lens is being worn on said eye comprising instilling to said eye, having said lens thereon, a fluid exchange improving effective amount of a comfort drop solution of claim 38, whereby said lens is temporarily flattened allowing for greater fluid exchange than is possible in the absence of said comfort drop solution of claim 38.

Claim 50

The method of claim 45 wherein said comfort drop is instilled in an amount of 1 to about 5 drops up to about 5 times daily.