Status:
COMPLETED
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Lead Sponsor:
Eyegate Pharmaceuticals, Inc.
Conditions:
Uveitis, Anterior
Eligibility:
All Genders
12-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with no...
Detailed Description
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infe...
Eligibility Criteria
Inclusion
- • Non-infectious anterior uveitis
Exclusion
- Uveitis of infectious etiology
- Previous anterior uveitis episode ≤ 4 weeks prior to baseline
- Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
- Topical corticosteroid treatment in either eye \< 48 hours prior to baseline
- Oral corticosteroid or intraorbital corticosteroid treatment in either eye \< 2 weeks prior to baseline
- Active intermediate or posterior uveitis
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00694135
Start Date
June 1 2008
End Date
August 1 2009
Last Update
August 31 2010
Active Locations (19)
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1
University of Miami
Miami, Florida, United States, 33136
2
Emory Eye Center
Atlanta, Georgia, United States, 30322
3
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
4
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, United States, 02142