Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

January 9, 2012 updated by: Kubota Vision Inc.

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 for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • The Eye Care Group, P.C.
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Richard Eiferman, MD
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Eye Care
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Total fluorescein corneal staining score
Time Frame: 4 weeks
4 weeks
Primary ocular discomfort
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Nancy Boman, MD, PhD, Kubota Vision Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 7, 2009

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

Other Study ID Numbers

  • ACU-RED-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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