Methods for Treating Eyetear Film Deficiency
The present invention relates to methods for treating tear film deficiencies in the eye by applying to the eye or the surrounding area an oil in water emulsion composition, optionally comprising a demulcent such as a hyaluronic acid compound.
1 . A method of treating, preventing, relieving or reducing the symptoms associated with tear film deficiency and/or tear film instability in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which treatment, prevention, relief or reduction is observed within about 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration.
2 . A method of increasing lacrimal secretion in a subject in one or both eyes of need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s) and/or lacrimal gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which increase can be observed within about 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration.
3 . A method of increasing meibomian gland secretion in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s) and/or the meibomian gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which increase can be observed within 1 day or more, about 10 days or more, 20 days or more, or 30 days or more, after such administration.
4 . A method of increasing tear film break up time in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which increase can be observed within 1 day or more, about 10 days or more, 20 days or more, or 30 days or more, after such administration.
5 . A method of treating, reducing, relieving or preventing low, decreased or decreasing tear film break up times in one or both eyes of a subject in need thereof due to meibomian gland dysfunction, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which treatment, prevention, relief or reduction can be observed within 1 day or more, about 10 days or more, 20 days or more, or 30 days or more, after such administration.
6 . A method of treating, reducing, relieving or preventing evaporative dry eye due to reduced or the inhibition or blockage of meibomian gland secretions in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which treatment, prevention, relief or reduction can be observed within about 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration.
7 . A method of preventing, reducing, relieving and/or treating meibomian gland and/or lacrimal gland dysfunction in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), the meibomian gland(s) and/or lacrimal glands of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which treatment, prevention or reduction can be observed within about 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration.
8 . A method of preventing, reducing, relieving and/or treating evaporative dry eye symptoms due to meibomian gland disfunction, lacrimal gland dysfunction and/or tear film instability in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising an oil-in-water emulsion to the eye(s), the meibomian gland(s) and/or lacrimal glands of the subject wherein the oil phase is present at a concentration of from about 0.01% w/v to about 10% w/v based on the total composition, which treatment, prevention or reduction can be observed within about 10 days or more, 20 days or more, or 30 days or more, after such administration.
9 . The method of claim 1 , wherein the oil phase comprises an oil or oily component selected from Castor oil, Coconut oil, Cod-liver oil, Corn oil, Olive oil, Peanut oil, Safflower oil, Soybean oil, Jojoba oil, silicone oil, Sunflower oil and mixtures thereof.
10 . The method of claim 9 , wherein the oil or oily component is Castor oil.
11 . The method of claim 1 , further comprising a demulcent.
12 . The method of claim 11 , wherein the demulcent is selected from a hyaluronic acid compound, carboxymethylcellulose, carboxy methyl cellulose methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, methyl ethyl cellulose, dextran 70, gelatin, polyethylene glycols, polyvinyl alcohol, povidone and the like and mixtures thereof.
13 . The method of claim 12 , wherein the demulcent is a hyaluronic acid compound.
14 . The method of claim 13 , wherein the hyaluronic acid compound is hyaluronic acid, any of its hyaluronate salts or mixtures thereof.
15 . The method of claim 14 , wherein the hyaluronic acid compound is hyaluronic acid.
16 . The method of claim 11 , wherein the demulcent is present in an amount of from about 0.01% w/v to about 5% w/v of the total composition.
17 . The method of claim 1 , wherein the composition further comprises surfactant.
18 . The method of claim 17 , wherein the surfactant is present in an amount from at least about 0.01 w/w % to no more than 5 w/w %, based on the total composition.
19 . The method of claim 18 , wherein the surfactant is selected from one or more of tocopherol polyethyleneglycol-succinate, PEG hydrogenated Castor oil, trihydroxystearate ester of polyethoxylated glycerol, hydroxystearate (bis)ester of mixed polyethylene glycols and mixtures thereof.
20 . The method of claim 19 , wherein the surfactant is selected from two or more of tocopherol polyethyleneglycol-succinate, PEG hydrogenated Castor oil, trihydroxystearate ester of polyethoxylated glycerol, hydroxystearate (bis)ester of mixed polyethylene glycols and mixtures thereof.
21 . The method of claim 20 , wherein the surfactant is PEG hydrogenated Castor oil.
22 . The method of claim 21 , wherein the PEG hydrogenated castor oil to Castor oil is in the range of 0.6 to 0.8 PEG hydrogenated castor oil for 1.0 w/w % Castor oil, or about 0.8 PEG hydrogenated castor oil for 1.0 w/w % Castor oil.
23 . The method of claim 1 , wherein the composition comprises 0.3% of an oil phase, which may comprise, consist or consist essentially of be castor oil.
24 . The method of claim 1 , wherein the step of administering comprises the step of administering an eye drop to the eyes in need thereof.
25 . The method of claim 24 , wherein the eye drop is administered at least once per day, at least twice per day, at least 3 times per day, 3 times per day, at least four times per day, at least five per day, at least six times per day, or as needed to the eyes in need thereof.
26 . The method of claim 24 , wherein the eye drop is administered every 12 hours, every 8 hours, every 6 hours every 4 hours, or as needed.
27 . The method of claim 24 , wherein the eye drops may be selected from multipurpose cleaning, rinsing, disinfecting and storage compositions, rewetting compositions, in-the-eye cleaning compositions.
28 . The method of claim 1 , wherein the step of administering comprises administering a contact lens that has been soaked in the composition prior to administration.
29 . The method of claim 28 , wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens.
30 . The method of claim 28 or 29 , where the contact lens is a daily disposable contact lens.
31 . The method of claim 28 or 29 , where the contact lens is a reusable contact lens and the contact lens is soaked in a composition used in any of the foregoing claims.
32 . The method of claim 1 , wherein the treatment, prevention, relief or reduction produces an increase in non-invasive tear film break-up time of at least about 10%, about 15% or about 20% compared to the eye without any treatment with the compositions of the present invention.
33 . The method of claim 1 , wherein the treatment, prevention, relief or reduction produces an increase in NITBUT of up to about 1 seconds, at least about 1 second, about 2 seconds, at least about 2 seconds compared to the eye without any treatment with the compositions.
34 . The method of claim 1 , wherein the treatment, prevention, relief or reduction produces an increase in NI I BUT of at least 10% or more, at least 15% or more, at least 20% compared to an untreated eye after one day, about 10 days, about 20 days, or about 30 days of administration of the composition.
35 . The method of claim 1 , wherein the treatment, prevention, relief or reduction produces an increase in NITBUT which treatment, prevention or reduction is observed within about 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 15 days, or 25 days of starting administration of the composition.
36 . The method of claim 1 , wherein the treatment, prevention, relief or reduction prevents, treats or reduces tear film deficiencies and contact lens water loss by providing an oil layer at the air-tear interface or additionally at the contact lens-tear interface when a contact lens is present.