Study of Dehydrex in Patients With Corneal Erosion

Not Applicable

Completed

• Conditions: Corneal Diseases; Recurrence

• Registration Number: NCT00029185
• Lead Sponsor: Holles Laboratories, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2001-09
• Status Verified: 2001-10
• Study First Submitted: 2002-01-08
• Study First Submitted QC: 2002-01-08
• Study First Posted: 2002-01-09
• Study Completion: 2007-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Holles Laboratories, Inc.; 🇺🇸 Cohasset, Massachusetts, United States