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

NCT05403827 | Completed Phase 3 Results FDA Drug

• 1 other identifier: K-161-3.01
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 51

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)

  Baseline to Day 85

• Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)

  Baseline to Day 85

• Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)

  Baseline to Day 85

• Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)

  Baseline to Day 85

• Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)

  Baseline to Day 85

Study Arms (2)

K-161

EXPERIMENTAL

K-161 Ophthalmic Solution

Drug: K-161

Placebo

PLACEBO COMPARATOR

Vehicle Solution

Drug: Placebo

Interventions

K-161 DRUG

K-161 Ophthalmic Solution

K-161

Placebo DRUG

Vehicle Solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have any clinically significant ocular condition
• Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (51)

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

Birmingham, Alabama, 35294, United States

Location

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Citrus Valley Eyecare / Premiere Practice Management, LLC

Covina, California, 91723, United States

Location

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Premiere Practice Management, LLC

Los Angeles, California, 90013, United States

Location

North Valley Eye Medical Group, Inc

Mission Hills, California, 91345, United States

Location

LoBue Laser and Eye Medical Center

Murrieta, California, 92562, United States

Location

Eye Research Foundation, Inc.

Newport Beach, California, 92663, United States

Location

Pendleton Eye Center

Oceanside, California, 92056, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Sierra Clinical Trial Research Organization

Santa Ana, California, 92705, United States

Location

Premiere Practice Management, LLC

Torrance, California, 90505, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Corneal Consultants of Colorado dba Colorado Eye Consultants

Littleton, Colorado, 80120, United States

Location

Segal Drug Trials

Delray Beach, Florida, 33484, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

Shettle Eye Research, Inc.

Largo, Florida, 33773, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

Dixophthal, PC.

Albany, Georgia, 31701, United States

Location

Edwin Yoshio Endo, OD & Associates & Interns

‘Aiea, Hawaii, 96701, United States

Location

Chicago Cornea Consultants

Hoffman Estates, Illinois, 60169, United States

Location

Jones Eye Clinic and Surgery Center

Sioux City, Iowa, 51104, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Midwest Vision Research Foundation at Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Wellish Vision Institute

Las Vegas, Nevada, 89119, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

Wake Forest Health Network, LLC

High Point, North Carolina, 27262, United States

Location

Insight Research Clinic, LLC dba EyeCare Professionals

Powell, Ohio, 43065, United States

Location

Conestoga Eye PC

Lancaster, Pennsylvania, 17601, United States

Location

Associates in Ophthalmology Ltd

West Mifflin, Pennsylvania, 15122, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Smyrna, Tennessee, 37167, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Hill Country Eye Center

Cedar Park, Texas, 78613, United States

Location

Southwest Eye Institute

El Paso, Texas, 79902, United States

Location

Lake Travis Eye and Laser Center/Revolution Research

Lakeway, Texas, 78738, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

DCT-Shah Research, LLC dba Discovery Clinical Trials

San Antonio, Texas, 78230, United States

Location

Northern Virginia Ophthalmology Associates

Falls Church, Virginia, 22042, United States

Location

Virginia Eye Consultants, Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Kowa Research Institute, Inc.

CTGResults@KowaUS.com

919-433-1600

Study Officials

• Andrey E. Belous, MD, PhD

  Kowa Pharma Development Co.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: July 3, 2022
• Primary Completion: August 25, 2023
• Study Completion: December 5, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

US (51)