Study of Dehydrex in Patients With Corneal Erosion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029185
Recruitment Status : Completed
First Posted : January 9, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : September 2001
Study Completion Date : September 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029185

United States, Massachusetts
Holles Laboratories, Inc.
Cohasset, Massachusetts, United States, 02025
Sponsors and Collaborators
Holles Laboratories, Inc. Identifier: NCT00029185     History of Changes
Other Study ID Numbers: FD-R-1984-01
First Posted: January 9, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: October 2001

Keywords provided by FDA Office of Orphan Products Development:
Corneal Erosion
Administration, Topical
Ophthalmic Solutions

Additional relevant MeSH terms:
Corneal Diseases
Disease Attributes
Pathologic Processes
Eye Diseases