Uveitis, Anterior Clinical Trial
Official title:
A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis
Verified date | August 2010 |
Source | Eyegate Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Narayana Nethralaya | Bangalore | Karnataka |
India | St. Johns Medical College and Hospital | Bangalore | Karnataka |
India | Vittala International Institute of Ophthalmology | Bangalore | Karnataka |
India | M. M. Joshi Eye Institute | Hubli | Karnataka |
India | Kasturba Medical College and Hospital | Manipal | Karnataka |
India | Christian Medical College | Vellore | Tamil Nadu |
United States | Emory Eye Center | Atlanta | Georgia |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
United States | Massachusetts Eye Research and Surgery Institution | Cambridge | Massachusetts |
United States | Cleveland Eye Clinic | Cleveland | Ohio |
United States | Texas Retina Associates | Dallas | Texas |
United States | Pennsylvania College of Optometry | Elkins Park | Pennsylvania |
United States | Southern College of Optometry | Memphis | Tennessee |
United States | University of Miami | Miami | Florida |
United States | New York Eye & Ear Infirmary | New York | New York |
United States | Virginia Eye Consultants | Norfolk | Virginia |
United States | Scheie Eye Institue | Philadelphia | Pennsylvania |
United States | Oregon Health Services University | Portland | Oregon |
United States | Comprehensive Eye Care Ltd. | Washington | Missouri |
Lead Sponsor | Collaborator |
---|---|
Eyegate Pharmaceuticals, Inc. |
United States, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with an ACC score of zero at Days 14 and 28 | Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28 | Prospective study, subjects followed for 28 days | Yes |
Secondary | Time to ACC score of zero | Time to anterior chamber cell score of zero | Prospective study, subjects followed for 28 days | Yes |
Secondary | Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28 | Proportion of subjects with a reduction of one full anterior chamber cell score or more (= 0.5 decrease) from baseline at Day 28 | Prospective study, subjects followed for 28 days | Yes |
Secondary | Change from baseline in ACC score at Day 28 | Change from baseline in anterior chamber cell score at Day 28 | Prospective study, subjects followed for 28 days | Yes |
Secondary | Treatment emergent adverse events | Treatment emergent adverse events | Prospective study, subjects followed for 28 days | Yes |
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