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K-161 Ophthalmic Solution for Dry Eye Disease
Phase 3
Waitlist Available
Research Sponsored by Kowa Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 85
Awards & highlights
Study Summary
This trial will test whether K-161 ophthalmic solution is effective and safe for treating moderate to severe dry eye disease.
Who is the study for?
This trial is for adults with moderate to severe dry eye disease who have used eye drops for this condition. Participants must be at least 18 years old and meet all other protocol requirements. Those with significant eye conditions or recent ocular surgery are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of K-161 ophthalmic solution compared to a placebo in treating dry eye disease. Participants will receive either the actual medication or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of K-161 are not listed, common side effects for ophthalmic solutions can include temporary discomfort, redness, blurred vision, watery eyes, or feeling like something is in your eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 85
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 moreSide effects data
From 2020 Phase 2 trial • 238 Patients • NCT0408448310%
Instillation site pain
2%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (BID) (Vehicle)
0.025% K-161 (BID)
0.1% K-161 (BID)
0.1% K-161 (QID)
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
K-161
2019
Completed Phase 3
~890
Find a Location
Who is running the clinical trial?
Kowa Research Institute, Inc.Lead Sponsor
44 Previous Clinical Trials
15,776 Total Patients Enrolled
Andrey E. Belous, MD, PhDStudy ChairKowa Pharma Development Co.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: K-161
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Colorado
Texas
Virginia
Other
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
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
2
0
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
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