A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Sponsored by Kowa Research Institute, Inc.
About this trial
Last updated 2 years ago
Study ID
K-161-3.01
Status
Active, not recruiting
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 months ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- 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
Exclusion Criteria
- 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