Clinical trial NCT05403827: A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in EDS (VAS) From Baseline to Day 85
timeFrame: Baseline to Day 85
measure: Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)
timeFrame: Baseline to Day 85
Secondary outcomes:
measure: Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)
timeFrame: Baseline to Day 85
measure: Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)
timeFrame: Baseline to Day 85
measure: Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)
timeFrame: Baseline to Day 85
measure: Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)
timeFrame: Baseline to Day 85
measure: Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)
timeFrame: Baseline to Day 85
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
state: Alabama
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Covina
country: United States
facility: Citrus Valley Eyecare / Premiere Practice Management, LLC
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Premiere Practice Management, LLC
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation, Inc.
state: California
city: Oceanside
country: United States
facility: Pendleton Eye Center
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Santa Ana
country: United States
facility: Sierra Clinical Trial Research Organization
state: California
city: Torrance
country: United States
facility: Premiere Practice Management, LLC
state: California
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Littleton
country: United States
facility: Corneal Consultants of Colorado dba Colorado Eye Consultants
state: Colorado
city: Delray Beach
country: United States
facility: Segal Drug Trials
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Albany
country: United States
facility: Dixophthal, PC.
state: Georgia
city: 'Aiea
country: United States
facility: Edwin Yoshio Endo, OD & Associates & Interns
state: Hawaii
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Sioux City
country: United States
facility: Jones Eye Clinic and Surgery Center
state: Iowa
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Garner
country: United States
facility: Oculus Research
state: North Carolina
city: High Point
country: United States
facility: Wake Forest Health Network, LLC
state: North Carolina
city: Powell
country: United States
facility: Insight Research Clinic, LLC dba EyeCare Professionals
state: Ohio
city: Lancaster
country: United States
facility: Conestoga Eye PC
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology Ltd
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Cedar Park
country: United States
facility: Hill Country Eye Center
state: Texas
city: El Paso
country: United States
facility: Southwest Eye Institute
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye and Laser Center/Revolution Research
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: DCT-Shah Research, LLC dba Discovery Clinical Trials
state: Texas
city: Falls Church
country: United States
facility: Northern Virginia Ophthalmology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Eye Consultants, Inc.
state: Virginia
Study officials:
affiliation: Kowa Pharma Development Co.
name: Andrey E. Belous, MD, PhD
role: STUDY_CHAIR
References: