Trial | NCT00029185  Report issue

Title

Study of Dehydrex in Patients With Corneal Erosion
Topical Dehydrex in Treating Recurrent Corneal Erosion

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dehydrex ...

  • Study Participants

    300
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.
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 Started
Sep 30
2001
Study Completion
Sep 30
2007
Last Update
Mar 25
2015
Estimate

Drug Dehydrex

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
No Results Posted