Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
NCT ID: NCT00694135
Last Updated: 2010-08-31
Study Results
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2008-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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
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
Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
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
Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
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
Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
12 Years
85 Years
ALL
No
Sponsors
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Eyegate Pharmaceuticals, Inc.
INDUSTRY
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
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
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
New York Eye & Ear Infirmary
New York, New York, United States
Cleveland Eye Clinic
Cleveland, Ohio, United States
Oregon Health Services University
Portland, Oregon, United States
Pennsylvania College of Optometry
Elkins Park, Pennsylvania, United States
Scheie Eye Institue
Philadelphia, Pennsylvania, United States
Southern College of Optometry
Memphis, Tennessee, United States
Texas Retina Associates
Dallas, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
St. Johns Medical College and Hospital
Bangalore, Karnataka, India
Vittala International Institute of Ophthalmology
Bangalore, Karnataka, India
Narayana Nethralaya
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, India
Countries
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Other Identifiers
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EGP-437-001
Identifier Type: -
Identifier Source: org_study_id