Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
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
1 other identifier
interventional
40
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 31, 2010
August 1, 2010
1.1 years
June 5, 2008
August 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Time to ACC score of zero
Prospective study, subjects followed for 28 days
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
Change from baseline in ACC score at Day 28
Prospective study, subjects followed for 28 days
Treatment emergent adverse events
Prospective study, subjects followed for 28 days
Study Arms (4)
EGP-437 1.6 mA-min at 0.4 mA
ACTIVE COMPARATOROcular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
EGP-437 4.8 mA-min at 1.2 mA
ACTIVE COMPARATOROcular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
EGP-437 10.0 mA-min at 2.5 mA
ACTIVE COMPARATOROcular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
EGP-437 14.0 mA-min at 3.5 mA
ACTIVE COMPARATOROcular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
Interventions
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Eligibility Criteria
You may qualify if:
- Non-infectious anterior uveitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Miami
Miami, Florida, 33136, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, 02142, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090, United States
New York Eye & Ear Infirmary
New York, New York, 10003, United States
Cleveland Eye Clinic
Cleveland, Ohio, 44195, United States
Oregon Health Services University
Portland, Oregon, 97239, United States
Pennsylvania College of Optometry
Elkins Park, Pennsylvania, 19027, United States
Scheie Eye Institue
Philadelphia, Pennsylvania, 19104, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
St. Johns Medical College and Hospital
Bangalore, Karnataka, 560 037, India
Vittala International Institute of Ophthalmology
Bangalore, Karnataka, 560 037, India
Narayana Nethralaya
Bangalore, Karnataka, 560010, India
M. M. Joshi Eye Institute
Hubli, Karnataka, 580 021, India
Kasturba Medical College and Hospital
Manipal, Karnataka, 576104, India
Christian Medical College
Vellore, Tamil Nadu, 632011, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C. Stephen Foster, MD
Massachusetts Eye Research and Surgery Institution
- PRINCIPAL INVESTIGATOR
Michael Raizman, MD
Ophthalmic Consultants of Boston
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2009
Study Completion
August 1, 2009
Last Updated
August 31, 2010
Record last verified: 2010-08