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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00694135
Other study ID # EGP-437-001
Secondary ID
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


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
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