This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued. Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only).
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
University of California, San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Wilmer Eye Institute/Johns Hopkins University
Baltimore, Maryland, United States
Montefiore Medical Center
The Bronx, New York, United States
Dose-limiting toxicity
Time frame: 56 days
Improvement on scleritis scale score
Time frame: 56 days
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Oregon Health & Sciences University
Portland, Oregon, United States
Scheie Eye Institute/University of Pennsylvania
Philadelphia, Pennsylvania, United States