At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 644 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.
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
In Brief
A Phase 3 clinical trial evaluating K-161 and Placebo for Dry Eye Disease. Completed, enrolled 644 participants across 51 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionAug 2023
Study CompletionDec 2023
TodayJul 2026
First PostedJun 3, 2022
Enrollment StartJul 3, 2022
Primary CompletionAug 25, 2023
Study CompletionDec 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago
Interventions
K-161drug
K-161 Ophthalmic Solution
Placebodrug
Vehicle Solution