Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

Phase 2

Completed

• Conditions: Keratoconjunctivitis Sicca; Dry Eye
• Interventions: Drug: rebamipide 2% ophthalmic suspension; Drug: placebo eye drops

• Registration Number: NCT01057147
• Lead Sponsor: Kubota Vision Inc.

Brief Summary

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 eye disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-27
• Study Start: 2010-02
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2012-01
• Disposition First Submitted: 2012-01-09
• Disposition First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Disposition First Posted: 2012-01-11
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Age 18 years and older
• Diagnosis of dry eye as defined by the protocol
• Central corneal staining

Exclusion Criteria

• Ongoing ocular disease that may interfere with study parameters
• Inability to stop using topical ophthalmic medications throughout the duration of the study
• Inability to stop the use of contact lenses for the duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rebamipide 2% ophthalmic suspension	rebamipide 2% ophthalmic suspension	-
placebo eye drops	placebo eye drops	-

Primary Outcome Measures

Name	Time	Method
Central corneal clearing as measured by fluorescein staining	12 weeks

Secondary Outcome Measures

Name	Time	Method
Ocular staining	12 weeks
Dry eye symptoms	12 weeks

Trial Locations

Locations (19)

Macy Eye Center; 🇺🇸 Los Angeles, California, United States

Cohen Laser and Vision Center; 🇺🇸 Boca Raton, Florida, United States

East Valley Ophthalmology; 🇺🇸 Mesa, Arizona, United States

Cornea Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Nevada Eye Care Professionals; 🇺🇸 Las Vegas, Nevada, United States

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States

Specialty Eye Care; 🇺🇸 Parker, Colorado, United States

Corneal Consultants of Colorado; 🇺🇸 Littleton, Colorado, United States

Ophthalmology Associates; 🇺🇸 St. Louis, Missouri, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

Med Eye Associates; 🇺🇸 Miami, Florida, United States

George R. John, MD; 🇺🇸 Louisville, Kentucky, United States

New York Ophthalmology, PC; 🇺🇸 Manhasset, New York, United States

Avista Eye Center; 🇺🇸 Las Vegas, Nevada, United States

Mundorf Eye Center; 🇺🇸 Charlotte, North Carolina, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

The Cataract & Glaucoma Center; 🇺🇸 El Paso, Texas, United States

Arizona Center for Clinical Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Florida Eye Microsurgical Institute, Inc.; 🇺🇸 Boynton Beach, Florida, United States