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

This study has been completed.
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00694135
First received: June 5, 2008
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eyegate Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Proportion of subjects with an ACC score of zero at Days 14 and 28 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]
    Change from baseline in anterior chamber cell score at Day 28

  • Treatment emergent adverse events [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]
    Treatment emergent adverse events


Enrollment: 40
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Dexamethasone Phosphate Ophthalmic Solution

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.

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694135

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory Eye Center
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, United States, 02142
United States, Missouri
Comprehensive Eye Care Ltd.
Washington, Missouri, United States, 63090
United States, New York
New York Eye & Ear Infirmary
New York, New York, United States, 10003
United States, Ohio
Cleveland Eye Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Services University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pennsylvania College of Optometry
Elkins Park, Pennsylvania, United States, 19027
Scheie Eye Institue
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Southern College of Optometry
Memphis, Tennessee, United States, 38104
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
India
Narayana Nethralaya
Bangalore, Karnataka, India, 560010
St. Johns Medical College and Hospital
Bangalore, Karnataka, India, 560 037
Vittala International Institute of Ophthalmology
Bangalore, Karnataka, India, 560 037
M. M. Joshi Eye Institute
Hubli, Karnataka, India, 580 021
Kasturba Medical College and Hospital
Manipal, Karnataka, India, 576104
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
  More Information

No publications provided

Responsible Party: Stephen From, President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00694135     History of Changes
Other Study ID Numbers: EGP-437-001
Study First Received: June 5, 2008
Last Updated: August 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Non-Infectious Acute Anterior Segment Uveitis
Ophthalmology

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Uveitis, Anterior
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2014