Study of Dehydrex in Patients With Corneal Erosion

Study Overview
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Brief Summary
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This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.

Detailed Description
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This study continues to provide Dehydrex to patients who have received it previously under other studies. Patients continue to be treated with their current dose of Dehydrex. Upward dose adjustments may be made as clinically indicated. Patients undergo eye exams every 3 to 4 months or more often. Downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. In patients who are able to discontinue the medication, duration of healing will be determined. In those patients who experience a recurrence after discontinuing the medication, Dehydrex will be restarted at a dose higher than the minimum effective dose. After at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. Further attempts to discontinue the medication will not be made. Completion date provided represents the completion date of the grant per OOPD records

Official Title
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Topical Dehydrex in Treating Recurrent Corneal Erosion

Conditions
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Corneal Diseases, Recurrence

Intervention / Treatment
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* Drug: Dehydrex


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion Not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses At least 3 episodes of erosion within the past 4 months documented by slit lamp examination Exclusion criteria: Allergy to any component of the medications to be used Active ocular surface infection due to bacteria, virus, or fungus Chronic atopic disease affecting the ocular surface or adnexa Dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy Concurrent use of contact lenses Diagnosis of persistent epithelial defect in eye to be treated Concurrent use of topical medication to eye to be treated Any ocular eyelid surgery within the past 6 months Pre-existing corneal stromal edema Diabetes mellitus Postsurgical infection Dry eye condition of 16 or greater on Patient's Dry Eye Questionnaire Other investigational medications within the past 6 months Other corneal dystrophy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dehydrex|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal