Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
Information source: Acucela Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratoconjunctivitis Sicca; Dry Eye
Intervention: rebamipide 2% ophthalmic suspension (Drug); placebo eye drops (Drug)
Phase: Phase 2
Sponsored by: Acucela Inc.
Official(s) and/or principal investigator(s):
Ryo Kubota, MD, PhD, Study Director, Affiliation: Acucela Inc.
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared
to placebo in clearing of fluorescein staining of the central cornea in subjects with dry
Official title: A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Central corneal clearing as measured by fluorescein staining
Dry eye symptoms
Minimum age: 18 Years.
Maximum age: N/A.
- Age 18 years and older
- Diagnosis of dry eye as defined by the protocol
- Central corneal staining
- Ongoing ocular disease that may interfere with study parameters
- Inability to stop using topical ophthalmic medications throughout the duration of the
- Inability to stop the use of contact lenses for the duration of the study
Locations and Contacts
East Valley Ophthalmology, Mesa, Arizona 85206, United States
Arizona Center for Clinical Trials, LLC, Phoenix, Arizona 85003, United States
Cornea Consultants of Arizona, Phoenix, Arizona 85032, United States
Macy Eye Center, Los Angeles, California 90048, United States
Corneal Consultants of Colorado, Littleton, Colorado 80120, United States
Specialty Eye Care, Parker, Colorado 80134, United States
Cohen Laser and Vision Center, Boca Raton, Florida 33431, United States
Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida 33426, United States
Med Eye Associates, Miami, Florida 33143, United States
George R. John, MD, Louisville, Kentucky 40205, United States
Central Maine Eye Care, Lewiston, Maine 04240, United States
Ora, Inc., Andover, Massachusetts 01810, United States
Ophthalmology Associates, St. Louis, Missouri 63131, United States
Avista Eye Center, Las Vegas, Nevada 89131, United States
Nevada Eye Care Professionals, Las Vegas, Nevada 89119, United States
New York Ophthalmology, PC, Manhasset, New York 11030, United States
Mundorf Eye Center, Charlotte, North Carolina 28204, United States
Black Hills Regional Eye Institute, Rapid City, South Dakota 57701, United States
The Cataract & Glaucoma Center, El Paso, Texas 79902, United States
Starting date: February 2010
Last updated: January 9, 2012