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

January 9, 2025 updated by: Kowa Research Institute, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
644

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in EDS (VAS) From Baseline to Day 85
Time Frame: 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)
Time Frame: 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.
Baseline to Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)
Time Frame: 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.
Baseline to Day 85
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)
Time Frame: 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
Baseline to Day 85
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)
Time Frame: Baseline to Day 85
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)
Time Frame: 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.
Baseline to Day 85
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)
Time Frame: 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).
Baseline to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kowa Research Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Andrey E. Belous, MD, PhD, Kowa Pharma Development Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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