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

NCT ID: NCT00694135

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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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

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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

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Uveitis, Anterior

Keywords

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Iontophoresis Non-Infectious Acute Anterior Segment Uveitis Ophthalmology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EGP-437 1.6 mA-min at 0.4 mA

Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA

Group Type ACTIVE_COMPARATOR

EGP-437 1.6 mA-min at 0.4 with EyeGate® II System

Intervention Type DRUG

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

Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA

Group Type ACTIVE_COMPARATOR

EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System

Intervention Type DRUG

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

Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA

Group Type ACTIVE_COMPARATOR

EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System

Intervention Type DRUG

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

Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA

Group Type ACTIVE_COMPARATOR

EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

Intervention Type DRUG

Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Phosphate Ophthalmic Solution Dexamethasone Phosphate Ophthalmic Solution Dexamethasone Phosphate Ophthalmic Solution Dexamethasone Phosphate Ophthalmic Solution

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eyegate Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Eyegate Pharmaceuticals, Inc.

Principal Investigators

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C. Stephen Foster, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye Research and Surgery Institution

Michael Raizman, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

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University of Miami

Miami, Florida, United States

Site Status

Emory Eye Center

Atlanta, Georgia, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Massachusetts Eye Research and Surgery Institution

Cambridge, Massachusetts, United States

Site Status

Comprehensive Eye Care Ltd.

Washington, Missouri, United States

Site Status

New York Eye & Ear Infirmary

New York, New York, United States

Site Status

Cleveland Eye Clinic

Cleveland, Ohio, United States

Site Status

Oregon Health Services University

Portland, Oregon, United States

Site Status

Pennsylvania College of Optometry

Elkins Park, Pennsylvania, United States

Site Status

Scheie Eye Institue

Philadelphia, Pennsylvania, United States

Site Status

Southern College of Optometry

Memphis, Tennessee, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

St. Johns Medical College and Hospital

Bangalore, Karnataka, India

Site Status

Vittala International Institute of Ophthalmology

Bangalore, Karnataka, India

Site Status

Narayana Nethralaya

Bangalore, Karnataka, India

Site Status

M. M. Joshi Eye Institute

Hubli, Karnataka, India

Site Status

Kasturba Medical College and Hospital

Manipal, Karnataka, India

Site Status

Christian Medical College

Vellore, Tamil Nadu, India

Site Status

Countries

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United States India

Other Identifiers

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EGP-437-001

Identifier Type: -

Identifier Source: org_study_id