The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

Last updated: December 21, 2014
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT00831662
P08637
03-113
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better

  • Central corneal staining of 3 on the NEI scale

  • If female, are non-pregnant or non-lactating

  • Have a history of dry eye disease in both eyes

  • Have normal lid anatomy

Exclusion

Exclusion Criteria:

  • Unable to withhold the use of contact lenses during the study or 2 weeks prior to thestudy

  • Have had ocular surface surgery within the past year

  • Are considered legally blind in one eye

  • Have a serious medical condition which could confound study assessments

Study Design

Total Participants: 490
Study Start date:
January 01, 2009
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Dr. Donald H. Farrell Ophthalmology

    Saint John, New Brunswick E2L 1G3
    Canada

    Site Not Available

  • Yorkville Eye Clinic

    Toronto, Ontario M5R 2G3
    Canada

    Site Not Available

  • Centre for Contact Lens Research, School of Optometry, University of Waterloo

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

  • Sall Research Medical Center

    Artesia, California 90701
    United States

    Site Not Available

  • United Medical Research Institute

    Inglewood, California 90302
    United States

    Site Not Available

  • North Valley Eye Medical Group

    Mission Hills, California 91345
    United States

    Site Not Available

  • David Wirta, MD, Inc.

    Newport Beach, California 92663
    United States

    Site Not Available

  • North Bay Eye Associates, Inc.

    Petaluma, California 94954
    United States

    Site Not Available

  • Martel Eye Medical Group

    Ranchero Cordova, California 95670
    United States

    Site Not Available

  • Wolstan Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Peter C. Donshik, MD, PC

    Bloomfield, Connecticut 06002
    United States

    Site Not Available

  • Eye Center

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • The Eye Associates

    Bradenton, Florida 34209
    United States

    Site Not Available

  • Hernando Eye Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Center For Excellence In Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • Marvin E. Greenberg, MD, LLC

    Tamarac, Florida 33321
    United States

    Site Not Available

  • International Eye Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • Wohl Eye Center

    Bloomingdale, Illinois 60108
    United States

    Site Not Available

  • Chicago Cornea Consultants, Ltd.

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • IU Eye at Carmel

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Eye Physicians and Surgeons, LLP

    Iowa City, Iowa 52245
    United States

    Site Not Available

  • Taustine Eye Center

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Minnesota Eye Consultants, P.A.

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Ophthalmology Associates

    St Louis, Missouri 63131
    United States

    Site Not Available

  • Comprehensive Eye Care Center

    Washington, Missouri 63090
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd

    Des Peres, Montana 63131
    United States

    Site Not Available

  • Las Vegas Physicians Research Group

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Robert Schultze, MD

    Delmar, New York 12054
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York 11563
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • South Shore Eye Care, LLP

    Wantagh, New York 11793
    United States

    Site Not Available

  • Mundorf Eye Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Abrams Eye Center

    Cleveland, Ohio 44115
    United States

    Site Not Available

  • Family Eye Group

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Philadelphia Eye Associates

    Philadelphia, Pennsylvania 19148
    United States

    Site Not Available

  • Glaucoma Consultants and Center for Eye Research, PA

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota 57701-7394
    United States

    Site Not Available

  • Eye Clinic of Austin

    Austin, Texas 78731
    United States

    Site Not Available

  • Corona Research Clinical Study

    El Paso, Texas 79904
    United States

    Site Not Available

  • MedTex Research

    Rosharon, Texas 77583
    United States

    Site Not Available

  • Corona Research Consultants, Inc

    San Antonio, Texas 78221
    United States

    Site Not Available

  • See Clearly Vision Group, LLC

    McLean, Virginia 22102
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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