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

Phase 2

Completed

Interventions: Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

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 non-infectious anterior segment uveitis.

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-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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
EGP-437 1.6 mA-min at 0.4 mA	EGP-437 1.6 mA-min at 0.4 with EyeGate® II System	Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
EGP-437 4.8 mA-min at 1.2 mA	EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System	Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
EGP-437 10.0 mA-min at 2.5 mA	EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System	Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
EGP-437 14.0 mA-min at 3.5 mA	EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System	Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with an ACC score of zero at Days 14 and 28	Prospective study, subjects followed for 28 days	Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28	Prospective study, subjects followed for 28 days	Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28
Change from baseline in ACC score at Day 28	Prospective study, subjects followed for 28 days	Change from baseline in anterior chamber cell score at Day 28
Treatment emergent adverse events	Prospective study, subjects followed for 28 days	Treatment emergent adverse events
Time to ACC score of zero	Prospective study, subjects followed for 28 days	Time to anterior chamber cell score of zero

Locations (19): University of Miami
🇺🇸
Miami, Florida, 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
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
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University of Miami
🇺🇸Miami, Florida, United States