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

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)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Keratoconjunctivitis Sicca
• Intervention / Treatment: Drug: rebamipide 2% ophthalmic suspension; Drug: placebo eye drops

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • East Valley Ophthalmology
    • Phoenix, Arizona, United States, 85003
      • Arizona Center for Clinical Trials, LLC
    • Phoenix, Arizona, United States, 85032
      • Cornea Consultants of Arizona
  • California
    • Los Angeles, California, United States, 90048
      • Macy Eye Center
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Corneal Consultants of Colorado
    • Parker, Colorado, United States, 80134
      • Specialty Eye Care
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Cohen Laser and Vision Center
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Institute, Inc.
    • Miami, Florida, United States, 33143
      • Med Eye Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • George R. John, MD
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc.
  • Missouri
    • St. Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Nevada Eye Care Professionals
    • Las Vegas, Nevada, United States, 89131
      • Avista Eye Center
  • New York
    • Manhasset, New York, United States, 11030
      • New York Ophthalmology, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Eye Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • El Paso, Texas, United States, 79902
      • The Cataract & Glaucoma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rebamipide 2% ophthalmic suspension	Drug: rebamipide 2% ophthalmic suspension; Instill one drop in each eye four times daily for 12 weeks.
Placebo Comparator: placebo eye drops	Drug: placebo eye drops; Instill one drop in each eye four times daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central corneal clearing as measured by fluorescein staining	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Dry eye symptoms	12 weeks
Ocular staining	12 weeks

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.
• Collaborators: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Ryo Kubota, MD, PhD, Kubota Vision Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Pharmaceutical Solutions; Ophthalmic Solutions; Rebamipide
• Other Study ID Numbers: ACU-RED-204