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

Sponsor

Eyegate Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00694135

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis, Anterior	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	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EGP-437 1.6 mA-min at 0.4 mA Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA	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 Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 4.8 mA-min at 1.2 mA Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA	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 Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 10.0 mA-min at 2.5 mA Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA	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 Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 14.0 mA-min at 3.5 mA Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA	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 Other Names: Dexamethasone Phosphate Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

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

Time to ACC score of zero [Prospective study, subjects followed for 28 days]
Time to anterior chamber cell score of zero
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136
2	Emory Eye Center	Atlanta	Georgia	United States	30322
3	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
4	Massachusetts Eye Research and Surgery Institution	Cambridge	Massachusetts	United States	02142
5	Comprehensive Eye Care Ltd.	Washington	Missouri	United States	63090
6	New York Eye & Ear Infirmary	New York	New York	United States	10003
7	Cleveland Eye Clinic	Cleveland	Ohio	United States	44195
8	Oregon Health Services University	Portland	Oregon	United States	97239
9	Pennsylvania College of Optometry	Elkins Park	Pennsylvania	United States	19027
10	Scheie Eye Institue	Philadelphia	Pennsylvania	United States	19104
11	Southern College of Optometry	Memphis	Tennessee	United States	38104
12	Texas Retina Associates	Dallas	Texas	United States	75231
13	Virginia Eye Consultants	Norfolk	Virginia	United States	23502
14	St. Johns Medical College and Hospital	Bangalore	Karnataka	India	560 037
15	Vittala International Institute of Ophthalmology	Bangalore	Karnataka	India	560 037
16	Narayana Nethralaya	Bangalore	Karnataka	India	560010
17	M. M. Joshi Eye Institute	Hubli	Karnataka	India	580 021
18	Kasturba Medical College and Hospital	Manipal	Karnataka	India	576104
19	Christian Medical College	Vellore	Tamil Nadu	India	632011

Sponsors and Collaborators

Eyegate Pharmaceuticals, Inc.

Investigators

Principal Investigator: C. Stephen Foster, MD, Massachusetts Eye Research and Surgery Institution
Principal Investigator: Michael Raizman, MD, Ophthalmic Consultants of Boston