- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00029185
Study of Dehydrex in Patients With Corneal Erosion
Topical Dehydrex in Treating Recurrent Corneal Erosion
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Cohasset, Massachusetts, United States, 02025
- Holles Laboratories, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FD-R-1984-01
- FD-R-001984-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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