Study of Dehydrex in Patients With Corneal Erosion

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Holles Laboratories, Inc.

Criteria

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