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

NCT05403827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2025-01-14

Study results available
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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

Interventions

DRUG

K-161

K-161 Ophthalmic Solution

DRUG

Placebo

Vehicle Solution

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrey E. Belous, MD, PhD · Kowa Pharma Development Co.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-03
Primary Completion
2023-08-25
Completion
2023-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403827 on ClinicalTrials.gov