A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Key facts

Study ID

NCT04084483

Run by

Kowa Research Institute, Inc.

People needed

238

Starts

2019-08-04

Expected to finish

2020-01-09

Last updated by the study team

2023-03-15

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 visit.
• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
• Meet all 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.
• Must not meet any other exclusion criteria outlined in the clinical study protocol.

Where it is running

• Eye Research Foundation — Newport Beach, California, United States
• Central Maine Eye Care — Lewiston, Maine, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Total Eye Care, P.A. — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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