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NCT05403827 Clinical Trial

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

Dry Eye Disease Clinical Trial

Official title:
A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05403827
Other study ID # K-161-3.01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 3, 2022
Est. completion date December 5, 2023

Study information
Verified date December 2023
Source Kowa Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 644
Est. completion date December 5, 2023
Est. primary completion date August 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 drop use for dry eye symptom - Meet all other inclusion criteria outlined in the clinical study protocol Exclusion Criteria: - Have any clinically significant ocular condition - Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months - Meet any other exclusion criteria outlined in the clinical study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• K-161
K-161 Ophthalmic Solution
• Placebo
Vehicle Solution

Locations
Country Name City State
United States Edwin Yoshio Endo, OD & Associates & Interns 'Aiea Hawaii
United States Dixophthal, PC. Albany Georgia
United States Asheville Eye Associates Asheville North Carolina
United States Keystone Research Austin Texas
United States The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center Birmingham Alabama
United States Hill Country Eye Center Cedar Park Texas
United States Midwest Vision Research Foundation at Pepose Vision Institute Chesterfield Missouri
United States Vision Institute Colorado Springs Colorado
United States Citrus Valley Eyecare / Premiere Practice Management, LLC Covina California
United States Segal Drug Trials Delray Beach Florida
United States Trinity Research Group Dothan Alabama
United States Southwest Eye Institute El Paso Texas
United States Northern Virginia Ophthalmology Associates Falls Church Virginia
United States Orange County Ophthalmology Medical Group Garden Grove California
United States Oculus Research Garner North Carolina
United States Global Research Management Glendale California
United States Seidenberg Protzko Eye Associates Havre De Grace Maryland
United States Inland Eye Specialists Hemet California
United States Wake Forest Health Network, LLC High Point North Carolina
United States Chicago Cornea Consultants Hoffman Estates Illinois
United States United Medical Research Institute Inglewood California
United States Bowden Eye & Associates Jacksonville Florida
United States Tauber Eye Center Kansas City Missouri
United States Lake Travis Eye and Laser Center/Revolution Research Lakeway Texas
United States Conestoga Eye PC Lancaster Pennsylvania
United States Shettle Eye Research, Inc. Largo Florida
United States Wellish Vision Institute Las Vegas Nevada
United States Corneal Consultants of Colorado dba Colorado Eye Consultants Littleton Colorado
United States Premiere Practice Management, LLC Los Angeles California
United States Total Eye Care, PA Memphis Tennessee
United States North Valley Eye Medical Group, Inc Mission Hills California
United States LoBue Laser and Eye Medical Center Murrieta California
United States Eye Research Foundation, Inc. Newport Beach California
United States Virginia Eye Consultants, Inc. Norfolk Virginia
United States Pendleton Eye Center Oceanside California
United States Cornea and Cataract Consultants of Arizona Phoenix Arizona
United States Insight Research Clinic, LLC dba EyeCare Professionals Powell Ohio
United States Martel Eye Medical Group Rancho Cordova California
United States Ophthalmology Associates Saint Louis Missouri
United States Tekwani Vision Center Saint Louis Missouri
United States DCT-Shah Research, LLC dba Discovery Clinical Trials San Antonio Texas
United States R and R Eye Research, LLC San Antonio Texas
United States Sierra Clinical Trial Research Organization Santa Ana California
United States Jones Eye Clinic and Surgery Center Sioux City Iowa
United States Advancing Vision Research Smyrna Tennessee
United States International Research Center Tampa Florida
United States Premiere Practice Management, LLC Torrance California
United States Wolstan and Goldberg Eye Associates Torrance California
United States West Bay Eye Associates Warwick Rhode Island
United States Comprehensive Eye Care, Ltd. Washington Missouri
United States Associates in Ophthalmology Ltd West Mifflin Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in eye dryness score (EDS) Baseline to Day 85
Primary Change in conjunctival sum fluorescein staining score. Baseline to Day 85
Secondary Change in total eye sum fluorescein staining score Baseline to Day 85
Secondary Change in corneal sum fluorescein staining score Baseline to Day 85
Secondary Change in ocular surface disease index (OSDI) Questionnaire Baseline to Day 85
Secondary Change in Schirmer's test Assessed by Schirmer Tear Test (length of moistened area (mm)) Baseline to Day 85
Secondary Change in tear film break-up time (TFBUT) TFBUT will be assessed using fluorescein solution and measured in seconds Baseline to Day 85
Secondary Safety and Tolerability of K-161 in participants with DED Safety and tolerability measured in terms of the number of treatment related adverse events (TEAEs) Baseline to Day 85
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