Eye drops for treatment of irritation not due to infection

Inventors

Dikstein, Shabtay

Assignees

Resdevco Research and Development Co Ltd

Abstract

A method for treatment of irritation or damage to corneal or conjunctival epithelial cells, particularly for irritation or damage to corneal or conjunctival epithelial cells due to severe Sjögren's syndrome, comprising applying topically to an affected eye an aqueous solution of glycerol characterized by a glycerol concentration of >1% (w/v), most preferably 2.5% (w/v). The method is effective even in the case of very low tear formation, and its effectiveness cannot be explained by the known humectant effect of glycerol.

Core Innovation

The invention describes a method for treating irritation or damage to conjunctival or corneal epithelial cells resulting from Sjögren’s syndrome. The method characterizes the Sjögren’s syndrome by determining a LIPCOF score and by determining a level of devitalization of the conjunctival or corneal epithelial cells using Rose Bengal staining and/or Lissamine Green staining, and further characterizes the syndrome by a value representing a level of tear production as measured by a Schirmer’s test.

The method applies at predetermined intervals an ophthalmic preparation to an affected eye, where the ophthalmic preparation comprises an aqueous solution comprising glycerol and a substance selected from hyaluronic acid and hyaluronate. Treatment is continued until at least one condition is met, including that a LIPCOF score is statistically significantly lowered without any statistically significant change in the value of the Schirmer’s test measurement, and that a statistically significant reduction in the level of devitalization is observed by Lissamine Green and/or Rose Bengal staining without any statistically significant change in the Schirmer’s test measurement.

The ophthalmic preparation used in the method is characterized by a glycerol concentration between 1.1% and 4% (w/v) and by a concentration of the hyaluronic acid/hyaluronate substance of 0.015% (w/v). The described approach targets non-infectious irritation and devitalization of corneal and conjunctival epithelial cells in Sjögren’s syndrome, including severe Sjögren’s syndrome with very low tear formation, while maintaining tear production as measured by the Schirmer’s test.

Claims Coverage

The partial content provides one independent claim. It combines measurement-driven characterization of Sjögren’s syndrome with a defined ophthalmic preparation and a success criterion tied to LIPCOF/devitalization improvements without statistically significant change in Schirmer tear production.

Independent claim coverage is centered on treating Sjögren’s syndrome-related irritation or damage to conjunctival or corneal epithelial cells using a glycerol aqueous ophthalmic preparation containing hyaluronic acid or hyaluronate, with a measurement-based characterization and a treatment endpoint requiring improvements in LIPCOF and/or devitalization without statistically significant changes in Schirmer tear production.

Stated Advantages

Documented Applications