A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Last updated: January 9, 2025
Sponsor: Kowa Research Institute, Inc.
Overall Status: Completed

Phase

3

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

Placebo

K-161

Clinical Study ID

NCT05403827
K-161-3.01
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be at least 18 years of age at the time of Informed Consent

  • Have a reported history of dry eye disease in both eyes and a history of eye dropuse for dry eye symptom

  • Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion

Exclusion Criteria:

  • Have any clinically significant ocular condition

  • Have a history of corneal refractive surgery and/or any other ocular surgicalprocedure within 12 months

  • Meet any other exclusion criteria outlined in the clinical study protocol

Study Design

Total Participants: 644
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 03, 2022
Estimated Completion Date:
December 05, 2023

Connect with a study center

  • The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Trinity Research Group

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Citrus Valley Eyecare / Premiere Practice Management, LLC

    Covina, California 91723
    United States

    Site Not Available

  • Orange County Ophthalmology Medical Group

    Garden Grove, California 92843
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Inland Eye Specialists

    Hemet, California 92545
    United States

    Site Not Available

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

  • Premiere Practice Management, LLC

    Los Angeles, California 90013
    United States

    Site Not Available

  • North Valley Eye Medical Group, Inc

    Mission Hills, California 91345
    United States

    Site Not Available

  • LoBue Laser and Eye Medical Center

    Murrieta, California 92562
    United States

    Site Not Available

  • Eye Research Foundation, Inc.

    Newport Beach, California 92663
    United States

    Site Not Available

  • Pendleton Eye Center

    Oceanside, California 92056
    United States

    Site Not Available

  • Martel Eye Medical Group

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Sierra Clinical Trial Research Organization

    Santa Ana, California 92705
    United States

    Site Not Available

  • Premiere Practice Management, LLC

    Torrance, California 90505
    United States

    Site Not Available

  • Wolstan and Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Vision Institute

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Corneal Consultants of Colorado dba Colorado Eye Consultants

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Segal Drug Trials

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Eye Associates of Fort Myers

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Bowden Eye & Associates

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Shettle Eye Research, Inc.

    Largo, Florida 33773
    United States

    Site Not Available

  • International Research Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • Dixophthal, PC.

    Albany, Georgia 31701
    United States

    Site Not Available

  • Edwin Yoshio Endo, OD & Associates & Interns

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Chicago Cornea Consultants

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Jones Eye Clinic and Surgery Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Seidenberg Protzko Eye Associates

    Havre De Grace, Maryland 21078
    United States

    Site Not Available

  • Midwest Vision Research Foundation at Pepose Vision Institute

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Ophthalmology Associates

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Tekwani Vision Center

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd.

    Washington, Missouri 63090
    United States

    Site Not Available

  • Wellish Vision Institute

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Asheville Eye Associates

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Oculus Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Wake Forest Health Network, LLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Insight Research Clinic, LLC dba EyeCare Professionals

    Powell, Ohio 43065
    United States

    Site Not Available

  • Conestoga Eye PC

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Associates in Ophthalmology Ltd

    West Mifflin, Pennsylvania 15122
    United States

    Site Not Available

  • West Bay Eye Associates

    Warwick, Rhode Island 02888
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Advancing Vision Research

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Hill Country Eye Center

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Southwest Eye Institute

    El Paso, Texas 79902
    United States

    Site Not Available

  • Lake Travis Eye and Laser Center/Revolution Research

    Lakeway, Texas 78738
    United States

    Site Not Available

  • DCT-Shah Research, LLC dba Discovery Clinical Trials

    San Antonio, Texas 78230
    United States

    Site Not Available

  • R and R Eye Research, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Northern Virginia Ophthalmology Associates

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Virginia Eye Consultants, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

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