CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 238 enrolled
Drug / intervention
K-161 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04084483
NCT04084483Phase 2Completed
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A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

Kowa Research Institute, Inc.·interventional·Posted Sep 10, 2019·Updated Mar 15, 2023

In Brief

A Phase 2 clinical trial evaluating K-161 and Placebo (Vehicle) for Dry Eye Disease. Completed, enrolled 238 participants across 4 sites.

Detailed Summary

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 10, 2019
Enrollment StartAug 4, 2019
Primary CompletionJan 9, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.8 years ago

Interventions

K-161drug

K-161 alternate dosage

Placebo (Vehicle)other

Placebo solution