Study of Dehydrex in Patients With Corneal Erosion

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: January 8, 2002
Last updated: March 24, 2015
Last verified: October 2001
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.

Condition Intervention
Corneal Diseases
Drug: Dehydrex

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topical Dehydrex in Treating Recurrent Corneal Erosion

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 300
Study Start Date: September 2001
Estimated Study Completion Date: September 2007
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00029185

United States, Massachusetts
Holles Laboratories, Inc.
Cohasset, Massachusetts, United States, 02025
Sponsors and Collaborators
Holles Laboratories, Inc.
  More Information

No publications provided Identifier: NCT00029185     History of Changes
Other Study ID Numbers: FD-R-1984-01, FD-R-001984-01
Study First Received: January 8, 2002
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Corneal Diseases
Disease Attributes
Eye Diseases
Pathologic Processes processed this record on December 01, 2015