Study of Dehydrex in Patients With Corneal Erosion

Sponsor

Holles Laboratories, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00029185

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases Recurrence	Drug: Dehydrex	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Topical Dehydrex in Treating Recurrent Corneal Erosion

Study Start Date :

Sep 1, 2001

Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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