Corneal Diseases, Recurrence
Conditions
Keywords
Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal
Brief summary
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.
Detailed description
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
Interventions
DRUGDehydrex
Sponsors
Holles Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed