Study of Dehydrex in Patients With Corneal Erosion

Holles Laboratories

Status

Completed

Conditions

Corneal Diseases

Recurrence

Treatments

Drug: Dehydrex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00029185

FD-R-001984-01

FD-R-1984-01

Details and patient eligibility

About

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

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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