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Compositions and treatment for eye diseases and disorders

Inactive Publication Date: 2015-08-06
NORDBOTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a new treatment for eye surface diseases or disorders, such as dry eye, using low doses of progesterone applied topically to the face outside of the eye. The inventors discovered that this treatment can improve symptoms of these diseases.

Problems solved by technology

If left untreated, dry eyes can lead to more serious problems such as chronic dry eye syndrome, inflammation of the ocular surface and epithelial cell damage, or even blindness.
It is generally accepted that dry eyes are caused by an abnormality in the quality or quantity of tears on the eye surface, such as tear imbalance, that could lead to a loss of proper lubrication and discomfort.
A reduction in tear production or increase in tear elimination will often lead to dry eye.
For example, imperfections of the lipid layer can increase tear evaporation rates, and insufficient production of mucus can destabilize the tear film and lead to tear film disruption.
Topical administration of these compositions in or near the eye can, however, cause further irritation, burning, or stinging in the eye, and the concentrations of the hormones used in these treatment methods are high enough such that systemic hormone exposure may be a concern.
Aqueous tear deficiency (ATD) is the most common cause of dry eye and is due to insufficient tear production from the lacrimal glands.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0042]Four females age 25-45, twelve females over the age of 45, and two males over the age of 45 were treated with 1% (n=17) or 4% (n=1) topical progesterone compositions the same as or similar to the formulations described above. Fifteen of the eighteen patients completed a McMonnies Dry Eye questionnaire and all eighteen reported one or more symptoms of dry eye disorder prior to treatment. McMonnies scores for all patients that completed the questionnaire ranged from 9-28 with an average score of 16.0. Generally, McMonnies scores over 20 indicate dry eye disorder whereas scores between 10 and 20 are generally suggestive of borderline dry eye.

[0043]All patients treated with 1% or 4% progesterone compositions reported some relief from the symptoms or discomfort each experienced prior to treatment. Many patients that had a history of chronic usage of over-the-counter lubricating eye drops reported their ability to reduce or eliminate the use of such drops following treatment.

example 2

Single Treatment Tear Breakup Time (TBUT)

[0044]Six patients were observed for changes in TBUT following a single administration of 1% progesterone composition. Prior to treatment, patients complete an OSDI survey to indicate the severity of dry eye symptoms. TBUT is determined by instilling fluorescein in the eye, waiting approximately two minutes and then measuring the time lapse in seconds between a blink and the appearance of the first dry spots on the cornea. Liquid fluorescein without any anesthetic is applied with a micropipette to the inferior cul-de-sac of the right eye. After two blinks, the tear film is examined using the broad-beam of a slit lamp with a blue filter. Time is measured until the first dry spots appear on the cornea. Following a single instillation of fluorescein, TBUT is measured up to three times in succession, each reading beginning with the patient blinking twice followed by staring. The entire procedure is repeated in the left eye. Approximately 100-200 ...

example 3

[0046]One patient with a history of chronic dry eye syndrome and heavy corneal staining was treated with absorbable punctal plugs, and approximately one month later began treatment with 1% progesterone. The same patient was treated approximately one year later with absorbable punctal plugs and continued treatment with 1% progesterone. The patient reported continued improvement of dry eye symptoms during the course of treatment. After approximately two years following the first punctal plug treatment, the patient reported no notable dry eye symptoms and presented little or no corneal staining.

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PUM

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Abstract

The invention relates to compositions and methods for treating eye diseases and disorders. More specifically, the invention provides compositions comprising progesterone and methods of treating ocular surface diseases and disorders comprising applying such compositions topically.

Description

TECHNICAL FIELD OF THE INVENTION[0001]The invention relates to compositions and methods for treating eye diseases and disorders. More specifically, the invention provides compositions comprising progesterone and methods of treating ocular surface diseases and disorders comprising applying such compositions topically.BACKGROUND OF THE INVENTION[0002]Tears protect the eyes from many kinds of external stimuli. It is estimated that over 30% of people suffer from some type of ocular surface disease or disorder, many being classified as suffering from dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS). DES refers to an ocular affliction characterized by a dryness sensation in the eye often accompanied by grittiness, tearing, burning, blurred vision, or a foreign-body sensation. If left untreated, dry eyes can lead to more serious problems such as chronic dry eye syndrome, inflammation of the ocular surface and epithelial cell damage, or even blindness. It is generally accepted tha...

Claims

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Application Information

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IPC IPC(8): A61K31/57A61K9/00
CPCA61K31/57A61K9/0014A61K9/0048A61P27/02A61P27/04
Inventor CHANG, WEI-WEISAWYER, KENNETH
Owner NORDBOTICS INC
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