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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694135
• Other study ID #: EGP-437-001
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2008
• Last updated: August 27, 2010
• Start date: June 2008
• Est. completion date: August 2009

Study information

• 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

Clinical Trial 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.

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 information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iridocyclitis
• Iritis
• Uveitis
• Uveitis, Anterior

Intervention

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
• 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
• 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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eyegate Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  India, 

Outcome

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