Dry Eye DiseasePhase 3NCT05403827

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

A Phase 3 study testing K-161 in people with Dry Eye Disease, run by Kowa Research Institute, Inc. at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease
What is being tested?: K-161
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 644 participants
Where: 51 sitesUnited States
Study dates: 3 Jul 2022to 5 Dec 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Edwin Yoshio Endo, OD & Associates & Interns
‘Aiea, Hawaii, 96701
Dixophthal, PC.
Albany, Georgia, 31701
Asheville Eye Associates
Asheville, North Carolina, 28803
Keystone Research
Austin, Texas, 78731
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
Birmingham, Alabama, 35294
Hill Country Eye Center
Cedar Park, Texas, 78613
Midwest Vision Research Foundation at Pepose Vision Institute
Chesterfield, Missouri, 63017
Vision Institute
Colorado Springs, Colorado, 80907
Citrus Valley Eyecare / Premiere Practice Management, LLC
Covina, California, 91723
Segal Drug Trials
Delray Beach, Florida, 33484
Trinity Research Group
Dothan, Alabama, 36301
Southwest Eye Institute
El Paso, Texas, 79902
Northern Virginia Ophthalmology Associates
Falls Church, Virginia, 22042
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Oculus Research
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Inland Eye Specialists
Hemet, California, 92545
Wake Forest Health Network, LLC
High Point, North Carolina, 27262
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
United Medical Research Institute
Inglewood, California, 90301
Bowden Eye & Associates
Jacksonville, Florida, 32256
Tauber Eye Center
Kansas City, Missouri, 64111
Lake Travis Eye and Laser Center/Revolution Research
Lakeway, Texas, 78738
Conestoga Eye PC
Lancaster, Pennsylvania, 17601
Shettle Eye Research, Inc.
Largo, Florida, 33773
Wellish Vision Institute
Las Vegas, Nevada, 89119
Corneal Consultants of Colorado dba Colorado Eye Consultants
Littleton, Colorado, 80120
Premiere Practice Management, LLC
Los Angeles, California, 90013
Total Eye Care, PA
Memphis, Tennessee, 38119
North Valley Eye Medical Group, Inc
Mission Hills, California, 91345
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Eye Research Foundation, Inc.
Newport Beach, California, 92663
Virginia Eye Consultants, Inc.
Norfolk, Virginia, 23502
Pendleton Eye Center
Oceanside, California, 92056
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Insight Research Clinic, LLC dba EyeCare Professionals
Powell, Ohio, 43065
Martel Eye Medical Group
Rancho Cordova, California, 95670
R and R Eye Research, LLC
San Antonio, Texas, 78229
DCT-Shah Research, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78230
Sierra Clinical Trial Research Organization
Santa Ana, California, 92705
Jones Eye Clinic and Surgery Center
Sioux City, Iowa, 51104
Advancing Vision Research
Smyrna, Tennessee, 37167
Tekwani Vision Center
St Louis, Missouri, 63128
Ophthalmology Associates
St Louis, Missouri, 63131
International Research Center
Tampa, Florida, 33603
Premiere Practice Management, LLC
Torrance, California, 90505
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
West Bay Eye Associates
Warwick, Rhode Island, 02888
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
Associates in Ophthalmology Ltd
West Mifflin, Pennsylvania, 15122

Other trials in United States

About this study

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

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
Being tested: K-161, Placebo
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

K-161Drug
K-161 Ophthalmic Solution
PlaceboDrug
Vehicle Solution

Study groups in NCT05403827
Study group	Role	What they receive
K-161	Experimental	K-161 Ophthalmic Solution Receives: Drug: K-161
Placebo	Placebo comparator	Vehicle Solution Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 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.
Measured: Baseline to Day 85

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 20225 Dec 2023

First posted3 Jun 2022
Study start3 Jul 2022
Primary completion25 Aug 2023
Study completion5 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 644 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403827
Sponsor's protocol ID: K-161-3.01
Status last verified: Jan 2025
First submitted: 31 May 2022
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05403827
Acronym / sponsor ID: K-161-3.01
Conditions: Dry Eye Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 644 participants (actual)
Lead sponsor: Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
Study start: 3 Jul 2022 (actual)
Primary completion: 25 Aug 2023 (actual)
Study completion: 5 Dec 2023 (actual)
First posted: 3 Jun 2022 (actual)
Results: Posted 14 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
K-161	Experimental	Drug: K-161K-161 Ophthalmic Solution
Placebo	Placebo comparator	Drug: PlaceboVehicle Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
K-161K-161 Ophthalmic Solution	Drug	K-161
PlaceboVehicle Solution	Drug	Placebo

Primary outcome

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".
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.

5 secondary outcomes

Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)
Time frame: 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

Results and safety

Results posted to the registry on 14 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
K-161	322	253
Vehicle	322	269

Primary outcome: Change in EDS (VAS) From Baseline to Day 85

Time frame: Baseline to Day 85. Mean (Standard Deviation). Unit: mm

Measure	K-161 n = 292	Vehicle n = 306
Value	-18.0 (25.10)	-19.4 (25.34)

K-161 vs Vehicle: p = 0.5019, Control-Based Mean Imputation

Population analysed: The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: • Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.

Primary outcome: Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)

Time frame: Baseline to Day 85. Mean (Standard Deviation). Unit: Score on a scale

Measure	K-161 n = 291	Vehicle n = 306
Value	-2.81 (3.661)	-3.25 (3.480)

K-161 vs Vehicle: p = 0.2028, Control-Based Mean Imputation

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
K-161 12-Week	3 of 321 (0.9%)	32 of 321 (10%)	0 of 321
Vehicle 12-Week	2 of 322 (0.6%)	0 of 322 (0%)	0 of 322
K-161 40-Week Extension	1 of 122 (0.8%)	0 of 122 (0%)	0 of 122
Vehicle 40-Week Extension	2 of 121 (1.7%)	0 of 121 (0%)	0 of 121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrey E. Belous, MD, PhD study chair

Kowa Pharma Development Co.

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-161 in people with Dry Eye Disease, run by Kowa Research Institute, Inc. at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EDS (VAS) From Baseline to Day 85 (time frame: Baseline to Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.