K-161 Ophthalmic Solution for Dry Eye Disease

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Kowa Research Institute, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing K-161 eye drops to see if they are safe and effective for people with moderate to severe dry eye disease. The drops help keep the eyes moist and reduce irritation.

Research Team

Andrey E. Belous, MD, PhD

Principal Investigator

Kowa Pharma Development Co.

Eligibility Criteria

This trial is for adults with moderate to severe dry eye disease who have used eye drops for this condition. Participants must be at least 18 years old and meet all other protocol requirements. Those with significant eye conditions or recent ocular surgery are excluded.

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

Treatment Details

Interventions

K-161 Ophthalmic Solution (Other)
Placebo (Other)

Trial OverviewThe study is testing the effectiveness and safety of K-161 ophthalmic solution compared to a placebo in treating dry eye disease. Participants will receive either the actual medication or a placebo without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: K-161Experimental Treatment1 Intervention

K-161 Ophthalmic Solution

Group II: PlaceboPlacebo Group1 Intervention

Vehicle Solution