Clinical trial NCT00201981: Study of Rebamipide Eye Drops to Treat Dry Eye
Official title: Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Keywords: dry eye
keratoconjunctivitis sicca
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2005-09-20
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Detailed description: There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptom.

Eligibility criteria: Inclusion Criteria:

* must have symptoms of dry eye for a minimum of 6 months
* must be able to sign and date an informed consent

Exclusion Criteria:

* presence of anterior segment disease
* glaucoma or ocular hypertension
* using Restasis
* use of topically instilled ocular medications during study
* use of contact lenses
* history of ocular surgery within 12 months
* females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
* presence of Stevens-Johnson syndrome
* any anticipated change in medication through-out study
* concurrent involvement in another study or previous receipt of this drug
* cannot be safely be weaned off of ocular medications

Primary outcomes:
measure: fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
timeFrame: 12 week and 26 week
Secondary outcomes:
measure: fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
timeFrame: 12 week and 26 week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Research Center, LLC
state: Alabama
city: Glendale
country: United States
facility: Sun Valley Arthritis Center, Ltd.
state: Arizona
city: Peoria
country: United States
facility: Pivotel Research Center
state: Arizona
city: Phoenix
country: United States
facility: Hope research Institute
state: Arizona
city: Phoenix
country: United States
facility: Buena Vista Eye Care Center
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Artesia
country: United States
facility: Sall Eye Research Center
state: California
city: Irvine
country: United States
facility: Radiant Research - Irvine
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: American Eye Institute
state: California
city: San Diego
country: United States
facility: Eye Clinic of San Diego
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Centennial
country: United States
facility: Centennial Eye Associates
state: Colorado
city: Littleton
country: United States
facility: Corneal Consultants of Colorado
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc.
state: Colorado
city: Bloomfield
country: United States
facility: Peter C. Donshik, MDPC
state: Connecticut
city: Waterbury
country: United States
facility: Opticare Eye Health Center
state: Connecticut
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Lake Worth
country: United States
facility: Radiant Research, Inc. - Lake Worth
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Eye Associates International
state: Florida
city: Pinellas Park
country: United States
facility: Pinellas Eye Center
state: Florida
city: Sunrise
country: United States
facility: Ft. Lauderdale Eye Institute
state: Florida
city: Tamarac
country: United States
facility: Marvin E. Greenberg, MD PA 7
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: International Eye Center
state: Florida
city: Atlanta
country: United States
facility: Omni Eye Services
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky, Department of Ophthamology
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Lions Eye Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research Associates, Inc.
state: Louisiana
city: Gretna
country: United States
facility: Danial Long, MD
state: Louisiana
city: New Orleans
country: United States
facility: Lakeview Optical
state: Louisiana
city: Bangor
country: United States
facility: Eye Center Northeast
state: Maine
city: Baltimore
country: United States
facility: Krieger Eye Institute
state: Maryland
city: Lutherville
country: United States
facility: The Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: New England Eye Center
state: Massachusetts
city: Peabody
country: United States
facility: The Eye Institute - Lahey Clinic North
state: Massachusetts
city: Ocean Springs
country: United States
facility: Mississippi Eye Associates
state: Mississippi
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: Orchard Park
country: United States
facility: Western New York Eye Center
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Raleigh
country: United States
facility: Orellana Retina Associates, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Comprehensive Opthalmology & Optical Services
state: Ohio
city: Perryberg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Northwest Corneal Services
state: Oregon
city: Roseburg
country: United States
facility: Vision Surgery and Laser Center
state: Oregon
city: Moon Township
country: United States
facility: West Hills Vision Center
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research
state: South Carolina
city: Maryville
country: United States
facility: University Eye Surgeons
state: Tennessee
city: Amarillo
country: United States
facility: St. Luke's Eye Institute
state: Texas
city: Austin
country: United States
facility: Eye Clinic of Austin
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Surgical Eye Associates, PA
state: Texas
city: Lake Jackson
country: United States
facility: Brazosport Eye Institute
state: Texas
city: Salt Lake City
country: United States
facility: Axia Research
state: Utah
city: Salt Lake City
country: United States
facility: John Moran Eye Center, University of Utah
state: Utah
city: Sandy
country: United States
facility: Physicians Research Options, LC
state: Utah
city: Fredericksburg
country: United States
facility: Access Eye Research Center
state: Virginia
Study officials:
affiliation: University of Louisville
name: Gary Foulks, MD
role: STUDY_CHAIR
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