drugset
drugset / Trial / NCT05403827

A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

NCT05403827 ↗

Phase 3 Completed 644 enrolled Kowa Research Institute, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-07-03
Primary completion
2023-08-25
Completion
2023-12-05

Outcome

Missed primary endpoint

registry analysis (superiority test); K-161 vs Vehicle; p = 0.5019; Control-Based Mean Imputation NCT05403827 ↗

registry analysis (superiority test); K-161 vs Vehicle; p = 0.2028; Control-Based Mean Imputation NCT05403827 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject K-161 Unknown — —

Indications

dry eye syndrome