Study of Dehydrex in Patients With Corneal Erosion
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2015 |
Start Date: | September 2001 |
End Date: | August 2004 |
Topical Dehydrex in Treating Recurrent Corneal Erosion
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal
erosion syndrome who have previously used Dehydrex.
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.
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.
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
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