NCT05403827

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	K-161	K-161 Ophthalmic Solution
DRUG	Placebo	Vehicle Solution

Timeline

• Start date: 2022-07-03
• Primary completion: 2023-08-25
• Completion: 2023-12-05
• First posted: 2022-06-03
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study