Clinical trial NCT00201955: 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, 26 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 symptoms.

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
Secondary outcomes:
measure: fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Harold Helms, MD
state: Alabama
city: Birmingham
country: United States
facility: Michael Bernstein, MD
state: Alabama
city: Flagstaff
country: United States
facility: I Care! Eye Care!
state: Arizona
city: Little Rock
country: United States
facility: Harvey and Bernice Jones Eye Institute
state: Arkansas
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: San Marino
country: United States
facility: Southern California Clinical Research, Inc.
state: California
city: Colorado Springs
country: United States
facility: Colorado Eye Associates, PC
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons, P.C.
state: Connecticut
city: Gainesville
country: United States
facility: Florida Ophthalmic Institute
state: Florida
city: Inverness
country: United States
facility: Florida Wellcare Alliance, L.C.
state: Florida
city: Largo
country: United States
facility: Shettle Eye Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tukio Institute for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Magnolia Research Group, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research - West Palm Beach
state: Florida
city: Savannah
country: United States
facility: Vision Incorporated
state: Georgia
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Wichita Clinic, PA
state: Kansas
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Bossier
country: United States
facility: Bossier Optical, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Stevenson Medical Surgical Eye Center
state: Louisiana
city: New Orleans
country: United States
facility: Family Eye Centers
state: Louisiana
city: N. Andover
country: United States
facility: Ophthalmic Research Associates, Inc.
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Eye Associates
state: Minnesota
city: Gulfport
country: United States
facility: Depremont Eye Specialists
state: Mississippi
city: Creve Coeur
country: United States
facility: Opthalmology Associates
state: Missouri
city: Piscataway
country: United States
facility: Clinical Research Laboratories
state: New Jersey
city: Princeton
country: United States
facility: Ophthalmology Associates
state: New Jersey
city: Bethpage
country: United States
facility: Eye Care Associates
state: New York
city: Lynbrook
country: United States
facility: Ophthmalmic Consultants of Long Island
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center School of Medicine
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Rockville Center
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Valley Stream
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Cary
country: United States
facility: Western Wake Eye Center, P.A.
state: North Carolina
city: Charlotte
country: United States
facility: Southeast Clinical Research Associates
state: North Carolina
city: Charlotte
country: United States
facility: Horizon Eye Care - Clinical Research Dept.
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Comprehensive Opthalmology & Optical Services
state: Ohio
city: Bend
country: United States
facility: Bend Medical Clinic
state: Oregon
city: Medford
country: United States
facility: Medical Eye Center
state: Oregon
city: Easton
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Glaucome-Cataract Consultants
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburg Eye and Ear Institute
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: El Paso
country: United States
facility: Corona Research Consultants, Inc.
state: Texas
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Physician Research Network
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
facility: Medical Center Ophthalmology
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Eye Clinic of South Texas
state: Texas
city: Milwaukee
country: United States
facility: Advanced Healthcare Clinical Research Center
state: Wisconsin
Study officials:
References: