Study of Dehydrex in Patients With Corneal Erosion

March 24, 2015 updated by: Holles Laboratories, Inc.

Topical Dehydrex in Treating Recurrent Corneal Erosion

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Cohasset, Massachusetts, United States, 02025
        • Holles Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

January 8, 2002

First Submitted That Met QC Criteria

January 8, 2002

First Posted (ESTIMATE)

January 9, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

October 1, 2001

More Information

Terms related to this study

Other Study ID Numbers

  • FD-R-1984-01
  • FD-R-001984-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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