Eye drops for treatment of irritation not due to infection
Inventors
Assignees
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Publication Number
US-11033513-B2
Publication Date
2021-06-15
Expiration Date
Abstract
A method for treatment of irritation or damage to conical or conjunctival epithelial cells, particularly for irritation or damage to corneal or conjunctival epithelial cells due to severe Sjögren's syndrome, by 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 relates to a method for treating irritation or damage to conjunctival or corneal epithelial cells resulting from Sjögren’s syndrome. The treatment comprises applying an ophthalmic preparation to an affected eye. The ophthalmic preparation consists of a solution of 2.5% glycerol (w/v), 0.05% Carbomer 981 (w/v), and the balance water.
The ophthalmic preparation is described as an aqueous glycerol solution for corneal and/or conjunctival epithelial cell irritation or damage caused by factors other than infection, including severe Sjögren’s syndrome. Controlled viscosity is provided by high-MW polymers, including hyaluronate and/or carbomer, and the preparation may be buffered and rendered isotonic. The document further describes embodiments in which the glycerol content is more than 1% and preferably 2.5%.
The document describes treatment with dosing and monitoring directed to epithelial cell damage. The severity and/or cell devitalization may be assessed using Rose Bengal staining or Lissamine Green staining, including grading such as Oxford grade. The document also describes prophylactic maintenance application after completing a therapeutic course to maintain significantly reduced irritation damage versus pre-treatment severity.
Claims Coverage
The partial content provides one independent claim, supported by dependent claims that refine patient context, assessment, dosing frequency, treatment duration, and prophylactic post-course maintenance. One inventive feature is identified for the independent claim, with main refinements summarized separately as dependent-feature items.
Glycerol-carbomer ophthalmic solution for Sjögren’s epithelial irritation/damage
A method for treating irritation or damage to conjunctival or corneal epithelial cells resulting from Sjögren’s syndrome by applying an ophthalmic preparation consisting of a solution of 2.5% glycerol (w/v), 0.05% Carbomer 981 (w/v), and the balance water.
Across the provided claims, the main inventive feature is the use of a specified ophthalmic preparation of 2.5% glycerol with 0.05% Carbomer 981 in water to treat conjunctival and/or corneal epithelial irritation or damage resulting from Sjögren’s syndrome. Dependent claims further specify assessment by Rose Bengal or Lissamine Green staining, frequency of application, treatment duration, and prophylactic post-course application to maintain reduced damage versus pre-treatment severity.
Stated Advantages
No side effects observed.
Improved ocular surface outcomes as assessed by objective staining measures, including moving toward no measurable damage by Oxford/Lissamine Green grading, while Schirmer values may remain low.
Improved LIPCOF and subjective OSDI outcomes compared with certain comparators.
Effects are described as not explainable by glycerol’s known moisturizing action.
Documented Applications
Treatment of irritation or damage to conjunctival or corneal epithelial cells resulting from Sjögren’s syndrome, including severe Sjögren’s syndrome.
Prophylactic application after completing a therapeutic course to maintain significantly reduced irritation damage versus pre-treatment severity.
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