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.
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-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
University of Miami
Miami, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
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
Time frame: Prospective study, subjects followed for 28 days
Time to ACC score of zero
Time to anterior chamber cell score of zero
Time frame: Prospective study, subjects followed for 28 days
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
Time frame: Prospective study, subjects followed for 28 days
Change from baseline in ACC score at Day 28
Change from baseline in anterior chamber cell score at Day 28
Time frame: Prospective study, subjects followed for 28 days
Treatment emergent adverse events
Treatment emergent adverse events
Time frame: Prospective study, subjects followed for 28 days
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Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
New York Eye & Ear Infirmary
New York, New York, United States
Cleveland Eye Clinic
Cleveland, Ohio, United States
Oregon Health Services University
Portland, Oregon, United States
Pennsylvania College of Optometry
Elkins Park, Pennsylvania, United States
Scheie Eye Institue
Philadelphia, Pennsylvania, United States
...and 9 more locations