K-161 for Dry Eye Syndrome (DES)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lake Travis Eye and Laser Center / Revolution Research, Lakeway, TX
Dry Eye Syndrome (DES)+3 More
K-161 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Dry Eye Syndrome (DES)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Dry Eye Syndrome (DES)

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Baseline to Day 85

Baseline to Day 85
Change in Schirmer's test
Change in conjunctival sum fluorescein staining score.
Change in corneal sum fluorescein staining score
Change in eye dryness score (EDS)
Change in ocular surface disease index (OSDI)
Change in tear film break-up time (TFBUT)
Change in total eye sum fluorescein staining score
Safety and Tolerability of K-161 in participants with DED

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Dry Eye Syndrome (DES)

Trial Design

2 Treatment Groups

K-161
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

620 Total Participants · 2 Treatment Groups

Primary Treatment: K-161 · Has Placebo Group · Phase 3

K-161
Drug
Experimental Group · 1 Intervention: K-161 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
K-161
2019
Completed Phase 2
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 85
Closest Location: Lake Travis Eye and Laser Center / Revolution Research · Lakeway, TX
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dry Eye Syndrome (DES)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.