ARTIFICIAL TEAR COMPOSITIONS AND METHODS OF USE THEREOF
The invention provides artificial tear compositions comprising one or more nonionic surfactants with one or more non-Newtonian viscosity enhancing excipients and menthol and methods of their use.
1 . An artificial tear composition comprising one or more nonionic surfactants, one or more viscosity enhancers, and menthol.
2 . The composition of claim 1 , further comprising a polyol and one or more electrolytes.
3 . The composition of claim 1 wherein the one or more nonionic surfactants are polysorbate 80, poloxamer 407, poloxamer 188 and polyoxyl castor oil.
4 . The composition of claim 1 , wherein the one or more viscosity enhancers are selected from cellulose derivatives.
5 . The composition of claim 2 , wherein the polyol is mannitol.
6 . The composition of claim 2 , wherein the one or more electrolytes are magnesium chloride and sodium chloride.
7 . The composition of claim 1 , further comprising a polyethylene glycol.
8 . The composition of claim 7 , wherein the polyethylene glycol is polyethylene glycol 400.
9 . The composition of claim 1 , further comprising ascorbic acid or d-alpha tocopherol.
10 . The composition of claim 1 , further comprising sorbate.
11 . The composition of claim 1 , wherein the total concentration of the one or more nonionic surfactants is from about 1.0% to about 10.0% w/v, wherein w/v denotes weight by total volume of the composition.
12 . The composition of claim 1 , wherein the total concentration of the one or more nonionic surfactants is from about 1.5% to about 5.9% w/v, wherein w/v denotes weight by total volume of the composition.
13 . The composition of claim 4 , wherein the cellulose derivative is at a concentration that provides a viscosity equivalent to hydroxypropylmethyl cellulose at a concentration from about 0.01% to about 1.5% w/v or high molecular weight carboxymethyl cellulose at a concentration from about 0.01% to about 1.5% w/v and wherein w/v denotes weight by total volume of the composition.
14 . The composition of claim 1 , wherein the menthol is at a concentration from about 0.01 to about 0.50 millimolar.
15 . An artificial tear composition comprising from about 1.00% to about 1.50% w/v polysorbate 80, from about 0.7% to about 1.00% w/v poloxamer 407, from about 0.20% to about 1.00% w/v poloxamer 188, from about 0.01% to about 0.30% w/v polyoxyl castor oil, from about 0.1% to about 1.5% w/v carboxymethyl cellulose and, from about 0.01 to about 0.50 millimolar menthol, wherein w/v denotes weight by total volume of the composition
16 . The composition of claim 15 , further comprising about 0.50% w/v polyethylene glycol 400, from about 0.75% to about 1.00% w/v mannitol, about 0.10% w/v magnesium chloride and about 0.35% to about 0.45% sodium chloride.
17 . The composition of claim 15 , further comprising from about 0.1% to about 0.15% w/v sorbate.
18 . The composition of claim 17 , wherein sorbate is at a concentration from about 0.11% to about 0.12% w/v.
19 . The composition of claim 15 , further comprising from about 0.25% to about 5.5% w/v hydroxypropyl-gamma-cyclodextrin.
20 . The composition of claim 15 , further comprising from about 1 to about 200 international units of d-alpha tocopherol.
21 . The composition of claim 15 , wherein the composition has a pH from about 5.7 to about 8.0.
22 . A method of treating dry eye comprising administering the composition of claim 1 to a subject in need thereof.