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Study of Dehydrex in Patients With Corneal Erosion

This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, October 2001

Sponsored by: 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

Drug Information available for:   Dextrans    Thimerosal   

U.S. FDA Resources

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
  More Information


Study ID Numbers:   FD-R-1984-01, FD-R-001984-01
First Received:   January 8, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00029185
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  

Study placed in the following topic categories:
Corneal Diseases
Eye Diseases
Recurrence
Dextrans

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 03, 2008




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