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

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: K-161
Drug: Placebo

Registration Number: NCT05403827

Lead Sponsor: Kowa Research Institute, Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 644

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K-161	K-161	K-161 Ophthalmic Solution
Placebo	Placebo	Vehicle Solution

Primary Outcome Measures

Name	Time	Method
Change in EDS (VAS) From Baseline to Day 85	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".
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)	Baseline to Day 85	* 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)	Baseline to Day 85	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.
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)	Baseline to Day 85	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).
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)	Baseline to Day 85	* 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.
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)	Baseline to Day 85	* 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
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)	Baseline to Day 85	OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

Trial Locations

Locations (50): Trinity Research Group
🇺🇸
Dothan, Alabama, United States
Orange County Ophthalmology Medical Group
🇺🇸
Garden Grove, California, United States
LoBue Laser and Eye Medical Center
🇺🇸
Murrieta, California, United States
Sierra Clinical Trial Research Organization
🇺🇸
Santa Ana, California, United States
Lake Travis Eye and Laser Center/Revolution Research
🇺🇸
Lakeway, Texas, United States
United Medical Research Institute
🇺🇸
Inglewood, California, United States
Seidenberg Protzko Eye Associates
🇺🇸
Havre De Grace, Maryland, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Wake Forest Health Network, LLC
🇺🇸
High Point, North Carolina, United States
West Bay Eye Associates
🇺🇸
Warwick, Rhode Island, United States
Martel Eye Medical Group
🇺🇸
Rancho Cordova, California, United States
Wolstan and Goldberg Eye Associates
🇺🇸
Torrance, California, United States
Edwin Yoshio Endo, OD & Associates & Interns
🇺🇸
'Aiea, Hawaii, United States
Corneal Consultants of Colorado dba Colorado Eye Consultants
🇺🇸
Littleton, Colorado, United States
Dixophthal, PC.
🇺🇸
Albany, Georgia, United States
Eye Research Foundation, Inc.
🇺🇸
Newport Beach, California, United States
Jones Eye Clinic and Surgery Center
🇺🇸
Sioux City, Iowa, United States
Vision Institute
🇺🇸
Colorado Springs, Colorado, United States
Advancing Vision Research
🇺🇸
Smyrna, Tennessee, United States
Tekwani Vision Center
🇺🇸
Saint Louis, Missouri, United States
Bowden Eye & Associates
🇺🇸
Jacksonville, Florida, United States
Associates in Ophthalmology Ltd
🇺🇸
West Mifflin, Pennsylvania, United States
Midwest Vision Research Foundation at Pepose Vision Institute
🇺🇸
Chesterfield, Missouri, United States
Segal Drug Trials
🇺🇸
Delray Beach, Florida, United States
Insight Research Clinic, LLC dba EyeCare Professionals
🇺🇸
Powell, Ohio, United States
R and R Eye Research, LLC
🇺🇸
San Antonio, Texas, United States
Northern Virginia Ophthalmology Associates
🇺🇸
Falls Church, Virginia, United States
Virginia Eye Consultants, Inc.
🇺🇸
Norfolk, Virginia, United States
Cornea and Cataract Consultants of Arizona
🇺🇸
Phoenix, Arizona, United States
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
🇺🇸
Birmingham, Alabama, United States
International Research Center
🇺🇸
Tampa, Florida, United States
Citrus Valley Eyecare / Premiere Practice Management, LLC
🇺🇸
Covina, California, United States
Global Research Management
🇺🇸
Glendale, California, United States
Premiere Practice Management, LLC
🇺🇸
Torrance, California, United States
Inland Eye Specialists
🇺🇸
Hemet, California, United States
Pendleton Eye Center
🇺🇸
Oceanside, California, United States
Shettle Eye Research, Inc.
🇺🇸
Largo, Florida, United States
Chicago Cornea Consultants
🇺🇸
Hoffman Estates, Illinois, United States
Comprehensive Eye Care, Ltd.
🇺🇸
Washington, Missouri, United States
Wellish Vision Institute
🇺🇸
Las Vegas, Nevada, United States
Oculus Research
🇺🇸
Garner, North Carolina, United States
Asheville Eye Associates
🇺🇸
Asheville, North Carolina, United States
Total Eye Care, PA
🇺🇸
Memphis, Tennessee, United States
Conestoga Eye PC
🇺🇸
Lancaster, Pennsylvania, United States
Southwest Eye Institute
🇺🇸
El Paso, Texas, United States
Hill Country Eye Center
🇺🇸
Cedar Park, Texas, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
🇺🇸
San Antonio, Texas, United States
Tauber Eye Center
🇺🇸
Kansas City, Missouri, United States
Keystone Research
🇺🇸
Austin, Texas, United States
North Valley Eye Medical Group, Inc
🇺🇸
Mission Hills, California, United States