A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Purpose
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.
Condition
- Dry Eye Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental K-161 |
K-161 Ophthalmic Solution |
|
|
Placebo Comparator Placebo |
Vehicle Solution |
|
More Details
- Status
- Completed
- Sponsor
- Kowa Research Institute, Inc.