Clinical trial NCT00694135: Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis, Anterior
Keywords: Iontophoresis
Non-Infectious Acute Anterior Segment Uveitis
Ophthalmology
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Proportion of subjects with an ACC score of zero at Days 14 and 28
timeFrame: Prospective study, subjects followed for 28 days
Secondary outcomes:
measure: Time to ACC score of zero
timeFrame: Prospective study, subjects followed for 28 days
measure: Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28
timeFrame: Prospective study, subjects followed for 28 days
measure: Change from baseline in ACC score at Day 28
timeFrame: Prospective study, subjects followed for 28 days
measure: Treatment emergent adverse events
timeFrame: Prospective study, subjects followed for 28 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Eye Research and Surgery Institution
state: Massachusetts
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd.
state: Missouri
city: New York
country: United States
facility: New York Eye & Ear Infirmary
state: New York
city: Cleveland
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health Services University
state: Oregon
city: Elkins Park
country: United States
facility: Pennsylvania College of Optometry
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institue
state: Pennsylvania
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Bangalore
country: India
facility: St. Johns Medical College and Hospital
state: Karnataka
city: Bangalore
country: India
facility: Vittala International Institute of Ophthalmology
state: Karnataka
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Hubli
country: India
facility: M. M. Joshi Eye Institute
state: Karnataka
city: Manipal
country: India
facility: Kasturba Medical College and Hospital
state: Karnataka
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
Study officials:
affiliation: Massachusetts Eye Research and Surgery Institution
name: C. Stephen Foster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Boston
name: Michael Raizman, MD
role: PRINCIPAL_INVESTIGATOR
References: