Study of Dehydrex in Patients With Corneal Erosion - Tabular View

Tracking Information
First Received Date ^ICMJE	January 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00029185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Dehydrex in Patients With Corneal Erosion
Official Title ^ICMJE	Topical Dehydrex in Treating Recurrent Corneal Erosion
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Condition ^ICMJE	Corneal Diseases Recurrence
Intervention ^ICMJE	Drug: Dehydrex
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	300
Completion Date	August 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00029185
Responsible Party
Study ID Numbers ^ICMJE	FD-R-1984-01, FD-R-001984-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	October 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP