Study of Dehydrex in Patients With Corneal Erosion

Recurrence Clinical Trial

Official title:

Topical Dehydrex in Treating Recurrent Corneal Erosion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029185
• Other study ID #: FD-R-1984-01
• Secondary ID: FD-R-001984-01
• Status: Completed
• Phase: N/A
• First received: January 8, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: September 2007

Study information

• Verified date: October 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Corneal Diseases
• Recurrence

Intervention

Drug:
• Dehydrex

Locations

Country	Name	City	State
United States	Holles Laboratories, Inc.	Cohasset	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Holles Laboratories, Inc.

Country where clinical trial is conducted

United States,