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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: K-161; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 644
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Covina, California, United States, 91723
      • Citrus Valley Eyecare / Premiere Practice Management, LLC
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Glendale, California, United States, 91204
      • Global Research Management
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Los Angeles, California, United States, 90013
      • Premiere Practice Management, LLC
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group, Inc
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation, Inc.
    • Oceanside, California, United States, 92056
      • Pendleton Eye Center
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Santa Ana, California, United States, 92705
      • Sierra Clinical Trial Research Organization
    • Torrance, California, United States, 90505
      • Wolstan and Goldberg Eye Associates
    • Torrance, California, United States, 90505
      • Premiere Practice Management, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
    • Littleton, Colorado, United States, 80120
      • Corneal Consultants of Colorado dba Colorado Eye Consultants
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Segal Drug Trials
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye & Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc.
    • Tampa, Florida, United States, 33603
      • International Research Center
  • Georgia
    • Albany, Georgia, United States, 31701
      • Dixophthal, PC.
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Edwin Yoshio Endo, OD & Associates & Interns
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic and Surgery Center
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation at Pepose Vision Institute
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Wellish Vision Institute
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates
    • Garner, North Carolina, United States, 27529
      • Oculus Research
    • High Point, North Carolina, United States, 27262
      • Wake Forest Health Network, LLC
  • Ohio
    • Powell, Ohio, United States, 43065
      • Insight Research Clinic, LLC dba EyeCare Professionals
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Conestoga Eye PC
    • West Mifflin, Pennsylvania, United States, 15122
      • Associates in Ophthalmology Ltd
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research
    • Cedar Park, Texas, United States, 78613
      • Hill Country Eye Center
    • El Paso, Texas, United States, 79902
      • Southwest Eye Institute
    • Lakeway, Texas, United States, 78738
      • Lake Travis Eye and Laser Center/Revolution Research
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC
    • San Antonio, Texas, United States, 78230
      • DCT-Shah Research, LLC dba Discovery Clinical Trials
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Northern Virginia Ophthalmology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-161; K-161 Ophthalmic Solution	Drug: K-161; K-161 Ophthalmic Solution
Placebo Comparator: Placebo; Vehicle Solution	Drug: Placebo; Vehicle Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EDS (VAS) From Baseline to Day 85	Eye Dryness Score (EDS) on Visual analog scale (VAS); Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".	Baseline to Day 85
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)	Assessed by expanded National Eye Institute (NEI) scale; Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed); Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.	Baseline to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)	Assessed by expanded National Eye Institute (NEI) scale.; Total eye sum will be assessed as the sum of Corneal sum fluorescein staining score and conjunctival sum fluorescein staining score.; Minimum is 0 and maximum is 44 for Total Eye Sum Fluorescein Staining Score.	Baseline to Day 85
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)	Assessed by expanded National Eye Institute (NEI) scale.; Corneal sum will be assessed as the sum of points in 5 corneal zones, and each zone will be graded on a 5-point scale from 0 - no punctate stain in the area to 4 - Severe diffuse (coalescent) macropunctate stain of the area (0.5 increments would be allowed); Minimum is 0 and maximum is 20 for Corneal Sum Fluorescein Staining Score	Baseline to Day 85
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)	OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.	Baseline to Day 85
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)	Length (mm) of the moistened area assessed by inserting a Schirmer test strip into the eye for 5 minutes to measure the production of tears.	Baseline to Day 85
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)	The time (in seconds) taken for the first dry spot to appear on the cornea after a complete blink (with the aid of a slit-lamp).	Baseline to Day 85

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.
• Investigators: Study Chair: Andrey E. Belous, MD, PhD, Kowa Pharma Development Co.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: K-161-3.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No