search
Back to results

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

Primary Purpose

Dry Eye Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
K-161
Placebo
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
  • Trinity Research Group
  • Cornea and Cataract Consultants of Arizona
  • Citrus Valley Eyecare / Premiere Practice Management, LLC
  • Orange County Ophthalmology Medical Group
  • Global Research Management
  • Inland Eye Specialists
  • United Medical Research Institute
  • Premiere Practice Management, LLC
  • North Valley Eye Medical Group, Inc
  • LoBue Laser and Eye Medical Center
  • Eye Research Foundation, Inc.
  • Pendleton Eye Center
  • Martel Eye Medical Group
  • Sierra Clinical Trial Research Organization
  • Premiere Practice Management, LLC
  • Wolstan and Goldberg Eye Associates
  • Vision Institute
  • Corneal Consultants of Colorado dba Colorado Eye Consultants
  • Segal Drug Trials
  • Bowden Eye & Associates
  • Shettle Eye Research, Inc.
  • International Research Center
  • Dixophthal, PC.
  • Edwin Yoshio Endo, OD & Associates & Interns
  • Chicago Cornea Consultants
  • Jones Eye Clinic and Surgery Center
  • Seidenberg Protzko Eye Associates
  • Midwest Vision Research Foundation at Pepose Vision Institute
  • Tauber Eye Center
  • Tekwani Vision Center
  • Ophthalmology Associates
  • Comprehensive Eye Care, Ltd.
  • Wellish Vision Institute
  • Asheville Eye Associates
  • Oculus Research
  • Wake Forest Health Network, LLC
  • Insight Research Clinic, LLC dba EyeCare Professionals
  • Conestoga Eye PC
  • Associates in Ophthalmology Ltd
  • West Bay Eye Associates
  • Total Eye Care, PA
  • Advancing Vision Research
  • Keystone Research
  • Hill Country Eye Center
  • Southwest Eye Institute
  • Lake Travis Eye and Laser Center/Revolution Research
  • R and R Eye Research, LLC
  • DCT-Shah Research, LLC dba Discovery Clinical Trials
  • Northern Virginia Ophthalmology Associates
  • Virginia Eye Consultants, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

K-161

Placebo

Arm Description

K-161 Ophthalmic Solution

Vehicle Solution

Outcomes

Primary Outcome Measures

Change in eye dryness score (EDS)
Change in conjunctival sum fluorescein staining score.

Secondary Outcome Measures

Change in total eye sum fluorescein staining score
Change in corneal sum fluorescein staining score
Change in ocular surface disease index (OSDI)
Questionnaire
Change in Schirmer's test
Assessed by Schirmer Tear Test (length of moistened area (mm))
Change in tear film break-up time (TFBUT)
TFBUT will be assessed using fluorescein solution and measured in seconds
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)

Full Information

First Posted
May 31, 2022
Last Updated
May 3, 2023
Sponsor
Kowa Research Institute, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05403827
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
620 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey E. Belous, MD, PhD
Organizational Affiliation
Kowa Pharma Development Co.
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Trinity Research Group
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Citrus Valley Eyecare / Premiere Practice Management, LLC
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Orange County Ophthalmology Medical Group
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Premiere Practice Management, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
North Valley Eye Medical Group, Inc
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
LoBue Laser and Eye Medical Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Eye Research Foundation, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Sierra Clinical Trial Research Organization
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Premiere Practice Management, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Corneal Consultants of Colorado dba Colorado Eye Consultants
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Segal Drug Trials
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Shettle Eye Research, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Dixophthal, PC.
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Edwin Yoshio Endo, OD & Associates & Interns
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Jones Eye Clinic and Surgery Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Midwest Vision Research Foundation at Pepose Vision Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Oculus Research
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Wake Forest Health Network, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Insight Research Clinic, LLC dba EyeCare Professionals
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Conestoga Eye PC
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Associates in Ophthalmology Ltd
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Advancing Vision Research
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Hill Country Eye Center
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Southwest Eye Institute
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Lake Travis Eye and Laser Center/Revolution Research
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DCT-Shah Research, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Northern Virginia Ophthalmology Associates
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Eye Consultants, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs