NCT00694135

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eyegate Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uveitis, Anterior

Interventions

Type	Name	Description
DRUG	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 delivered via EyeGate® II Drug Delivery System
DRUG	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 delivered via EyeGate® II Drug Delivery System
DRUG	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 delivered via EyeGate® II Drug Delivery System
DRUG	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 delivered via EyeGate® II Drug Delivery System

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-06-10
• Last updated: 2010-08-31

Locations

19 sites across 2 countries: United States, India