Study of Dehydrex in Patients With Corneal Erosion

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, October 2001

First Received: January 8, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00029185

Purpose

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 Recurrence	Drug: Dehydrex

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
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:	August 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029185

Locations

United States, Massachusetts
Holles Laboratories, Inc.	Recruiting
Cohasset, Massachusetts, United States, 02025
Contact: Peter G. Lelecas, B.S. 781-383-0741
Principal Investigator: Peter G. Lelecas, B.S.

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

Study ID Numbers:	FD-R-1984-01, FD-R-001984-01
Study First Received:	January 8, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00029185 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Corneal Erosion
Dextrans
Administration, Topical
Ophthalmic Solutions
Thimerosal

Additional relevant MeSH terms:

Corneal Diseases
Disease Attributes
Pathologic Processes
Eye Diseases
Recurrence

ClinicalTrials.gov processed this record on November 25, 2009