Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

April 17, 2014 updated by: Kubota Vision Inc.

A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

564

Phase

  • Phase 3

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
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Artesia, California, United States
      • Glendale, California, United States
      • Inglewood, California, United States
      • San Diego, California, United States
    • Colorado
      • Wheat Ridge, Colorado, United States
    • Florida
      • Fort Myers, Florida, United States
      • Miami, Florida, United States
      • Plantation, Florida, United States
      • Stuart, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Morrow, Georgia, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Lutherville, Maryland, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
      • Washington, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Princeton, New Jersey, United States
    • New York
      • Rochester, New York, United States
      • Rockville Centre, New York, United States
      • Valley Stream, New York, United States
      • Wantagh, New York, United States
    • North Carolina
      • Ashville, North Carolina, United States
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Mason, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of dry eye-related ocular symptoms for at least 20 months.
  • Meet protocol-defined criteria for corneal and conjunctival staining.
  • Meet protocol-defined criteria for ocular discomfort.

Exclusion Criteria:

  • Active anterior segment ocular disease other than dry eye syndrome.
  • Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
  • Inability to suspend the use of contact lenses for the duration of the study.
  • Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
  • Received any other investigational product within 4 months before the screening visit.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo (vehicle)
Drug: Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.
EXPERIMENTAL: Rebamipide 2% ophthalmic suspension
Drug: Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary ocular sign: Fluorescein corneal staining total score
Time Frame: 4 weeks
4 weeks
Primary ocular symptom: Worst ocular symptom severity score
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluorescein corneal staining total score
Time Frame: 2 weeks
2 weeks
Worst ocular symptom severity score
Time Frame: 2 weeks
2 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: Acucela Medical Monitor, 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

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (ESTIMATE)

July 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACU-RED-301

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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