Overview

Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
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 non-infectious anterior segment uveitis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eyegate Pharmaceuticals, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

- 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