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K-161 for Dry Eye Syndrome

Jones Eye Clinic and Surgery Center, Sioux City, IA
K-161 +1 morePhase 3Waitlist AvailableResearch Sponsored by Kowa Research Institute, Inc.

Study Summary

This trial will test whether K-161 ophthalmic solution is effective and safe for treating moderate to severe dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have dry eye disease in both eyes and have used eye drops to treat it.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in conjunctival sum fluorescein staining score.
Change in eye dryness score (EDS)
Secondary outcome measures
Change in Schirmer's test
Change in corneal sum fluorescein staining score
Change in ocular surface disease index (OSDI)
+3 more

Side effects data

From 2020 Phase 2 trial • 238 Patients • NCT04084483
Instillation site pain
Study treatment Arm
0.025% K-161 (BID)
Placebo (BID) (Vehicle)
0.1% K-161 (BID)
0.1% K-161 (QID)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: K-161Experimental Treatment1 Intervention
K-161 Ophthalmic Solution
Group II: PlaceboPlacebo Group1 Intervention
Vehicle Solution
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
43 Previous Clinical Trials
15,731 Total Patients Enrolled
Andrey E. Belous, MD, PhDStudy ChairKowa Pharma Development Co.

Media Library

K-161 Ophthalmic Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05403827 — Phase 3
Dry Eye Syndrome Research Study Groups: K-161, Placebo
Dry Eye Syndrome Clinical Trial 2023: K-161 Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT05403827 — Phase 3
K-161 Ophthalmic Solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403827 — Phase 3
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05403827 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the risks associated with taking K-161?

"K-161 is safe according to our estimation because it has reached Phase 3 in clinical trials. This means that, not only is there data supporting its efficacy, but also that multiple rounds of testing have been conducted to support its safety."

Answered by AI

Can people with the necessary conditions enroll in this trial currently?

"That is right, the clinical trial is currently recruiting patients. The first posting was on June 1st, 2022 and there have been no changes since May 31st, 2022. They are looking to enroll 620 people from a single site."

Answered by AI

How many volunteers are enrolled in this clinical trial?

"That is correct, the listing on clinicaltrials.gov verifies that this research project is looking for volunteers right now. This specific trial was first announced on 6/1/2022 and has been updated as recently as 5/31/2022. A total of 620 individuals are needed from 1 different locations."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Wellish Vision Institute
Cornea and Cataract Consultants of Arizona
Lake Travis Eye and Laser Center / Revolution Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

Tired of having dry eyes sucks. I've tried many different things to help my dry eyes and am eager to be part of a study.
PatientReceived 1 prior treatment
I have tried numerous prescription eye drops for dry eyes and nothing as completely helped me.
PatientReceived 2+ prior treatments
First, I enjoy the opportunity to make a contribution to my community. Second, receiving help is naturally a priority.
PatientReceived 1 prior treatment
I have tried artificial teardrops and I need a better treatment for my condition and to contribute in the development of new treatments.No other medication have used before to treat this.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do the screenings take?
PatientReceived no prior treatments
~266 spots leftby Nov 2024