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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT05403827

Run by

Kowa Research Institute, Inc.

People needed

644

Starts

2022-07-03

Expected to finish

2023-12-05

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be at least 18 years of age at the time of Informed Consent
• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
• Meet all other inclusion criteria outlined in the clinical study protocol

You may not qualify if…

• Have any clinically significant ocular condition
• Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
• Meet any other exclusion criteria outlined in the clinical study protocol

Where it is running

• The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center — Birmingham, Alabama, United States
• Trinity Research Group — Dothan, Alabama, United States
• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Citrus Valley Eyecare / Premiere Practice Management, LLC — Covina, California, United States
• Orange County Ophthalmology Medical Group — Garden Grove, California, United States
• Global Research Management — Glendale, California, United States
• Inland Eye Specialists — Hemet, California, United States
• United Medical Research Institute — Inglewood, California, United States
• Premiere Practice Management, LLC — Los Angeles, California, United States
• North Valley Eye Medical Group, Inc — Mission Hills, California, United States
• LoBue Laser and Eye Medical Center — Murrieta, California, United States
• Eye Research Foundation, Inc. — Newport Beach, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Sierra Clinical Trial Research Organization — Santa Ana, California, United States
• Premiere Practice Management, LLC — Torrance, California, United States
• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Vision Institute — Colorado Springs, Colorado, United States
• Corneal Consultants of Colorado dba Colorado Eye Consultants — Littleton, Colorado, United States
• Segal Drug Trials — Delray Beach, Florida, United States
• Bowden Eye & Associates — Jacksonville, Florida, United States
• Shettle Eye Research, Inc. — Largo, Florida, United States
• International Research Center — Tampa, Florida, United States
• Dixophthal, PC. — Albany, Georgia, United States
• Keystone Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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