Study of Dehydrex in Patients With Corneal Erosion

Recurrence Clinical Trial

Official title: Topical Dehydrex in Treating Recurrent Corneal Erosion

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

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

Related Conditions & MeSH terms

• Corneal Diseases
• Recurrence

• NCT number: NCT00029185
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: N/A
• Start date: September 2001
• Completion date: September 2007