ARTIFICIAL TEAR COMPOSITIONS AND METHODS OF USE THEREOF
The invention provides artificial tear compositions comprising a means for inducing tears and a means for sequestering tears. The invention further provides methods for treating dry eye, ocular surface defects, deficiencies or diseases, eye pain and Meibomian gland dysfunction.
1 . An artificial tear composition comprising a means for inducing tears and a means for sequestering tears.
2 . The composition of claim 1 , wherein the means for inducing tears is selected from a pH from about 5 to about 6, a terpenoid and an osmolarity of from about 270 to about 550 milliosmoles.
3 . The composition of claim 1 , wherein the means for sequestering tears comprises from about 1.5% to about 5.9% w/v total volume of one or more nonionic surfactants and one or more viscosity enhancers, wherein the one or more viscosity enhancers provides a viscosity of from about 50 to about 10,000 centipoise at 0 shear to 1 second.
4 . The composition of claim 3 , wherein the one or more nonionic surfactants are selected from the group consisting of polysorbates, poloxamers, polyoxyl castor oils, cyclodextrins, and combinations thereof.
5 . The composition of claim 3 , wherein the one or more viscosity enhancers are selected from the group consisting of cellulose derivatives, carbomers, gums, and hyaluronic acids, dextrans, polyvinyl alcohol, polyacrylic acids, povidone, polyethylene glycols, propylene glycol, chitosans and combinations thereof.
6 . The composition of claim 5 , wherein the one or more viscosity enhancers are selected from the group consisting of cellulose derivatives, carbomers, polyvinyl alcohol, polyethylene glycols and combinations thereof.
7 . The composition of claim 3 , further comprising a polyol.
8 . The composition of claim 7 , wherein the polyol is selected from the group consisting of mannitol, xylitol, sorbitol, isosorbide, erythritol, glycerol, maltitol and a combination thereof.
9 . The composition of claim 3 , further comprising one or more electrolytes.
10 . The composition of claim 9 , wherein the one or more electrolytes are selected from magnesium ions, sodium chloride, potassium chloride and a combination thereof.
11 . The composition of claim 3 , further comprising one or more lipids.
12 . The composition of claim 11 , wherein the one or more lipids is an omega 3 fatty acid.
13 . An artificial tear composition comprising:
from about 2.0% to about 4.0% w/v of one or more nonionic surfactants selected from the group consisting of polysorbates, poloxamers, polyoxyl castor oils and combinations thereof;
from about 0.5% to about 2.0% w/v of a viscosity enhancer selected from the group consisting of carboxymethyl cellulose and carbomer 940;
from about 1.0% to about 5.0% w/v mannitol;
from about 0.5% to about 1.0% w/v of a polyethylene glycol having a molecular weight
from about 400 to about 20,000 Daltons;
from about 0.1% to about 2.0% w/v sodium chloride;
from about 0.1% to about 0.12% w/v sorbate;
from about 3.0 to about 10.0 millimolar citrate buffer,
wherein w/v denotes weight by total volume of the composition and wherein the composition has a pH from about 5.0 to about 7.4.
14 . The composition of claim 13 , further comprising from about 0.25 to about 4.00 millimolar menthol.
15 . The composition of claim 13 , further comprising from about 0.07% to about 0.1% w/v magnesium chloride.
16 . The composition of claim 13 , further comprising an excipient selected from the group consisting of about 0.1% w/v ethylenediaminetetraacetic acid, from about 0.1% to about 0.5% w/v polyvinyl alcohol and a combination thereof.
17 . An artificial tear composition comprising:
a surfactant selected from the group consisting of about 3.50% w/v poloxamer 407 or about 0.25% w/v poloxamer 407 and 1.75% w/v sorbitol;
about 0.25% w/v polyoxyl 40 castor oil;
about 0.75% w/v of a polyethylene glycol having a molecular weight from about 400 to about 20,000 Daltons;
about 1.00% w/v mannitol;
from about 0.45% to about 0.75% sodium chloride;
from about 0.90% to about 1.20% w/v carbomer 940;
from about 0.4 to about 2.75 millimolar menthol;
about 4.00 millimolar citrate buffer;
about 0.10% w/v ethylenediaminetetraacetic acid;
about 0.10% w/v polyvinyl alcohol; and
about 0.12% w/v sorbate.
18 . A method of treating dry eye comprising administering the composition of claim 1 to a subject in need thereof.
19 . A method of treating ocular surface defects, deficiencies or diseases selected from the group consisting of superficial punctate keratitis, epithelial abrasions, post-surgical ocular surface abnormalities, dry eye following incisional or ablative surgery, ocular surface abnormalities caused by medication, preservatives, contact lens solution and contact lens use comprising administering the composition of claim 1 to a subject in need thereof.
20 . A method of treating endophthalmitis comprising administering the composition of claim 1 to a subject in need thereof.
21 . A method of treating eye pain comprising administering the composition of claim 1 to a subject in need thereof.
22 . A method of treating Meibomian gland dysfunction comprising administering the composition of claim 1 to a subject in need thereof.