Study of Dehydrex in Patients With Corneal Erosion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00029185
First received: January 8, 2002
Last updated: June 23, 2005
Last verified: October 2001
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topical Dehydrex in Treating Recurrent Corneal Erosion

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00029185     History of Changes
Other Study ID Numbers: FD-R-1984-01, FD-R-001984-01
Study First Received: January 8, 2002
Last Updated: June 23, 2005
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
Recurrence
Eye Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014