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Home > "S" Clinical Trials Conditions > Study of Dehydrex in Patients with Corneal Erosion  Study of Dehydrex in Patients with Corneal Erosion
Study of Dehydrex in Patients with Corneal Erosion
For Condition: Recurrence,Corneal Diseases
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 300
Location and Contact Information:
Holles Laboratories, Inc. *Recruiting*
Cohasset, Massachusetts, 02025
United States
Recruiting Peter Lelecas 781-383-0741
Additional Information:
Study ID Numbers: FD-R-1984-01; FD-R-001984-01
Study Start Date: September 2001
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029185
Other Recurrence Studies:
1. Study of Dehydrex in Patients with Corneal Erosion
2. Cornea Donor Study (CDS)
3. Dynamic Light Scattering and Keratoscopy for Corneal Examination
Related Studies:
Other Recurrence Clinical Trials
Other Massachusetts Clinical Trials
Other Cohasset Clinical Trials
Study of Dehydrex in Patients with Corneal Erosion
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