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

ArmDescriptionAssigned Intervention
Experimental
K-161
K-161 Ophthalmic Solution
  • Drug: K-161
    K-161 Ophthalmic Solution
Placebo Comparator
Placebo
Vehicle Solution
  • Drug: Placebo
    Vehicle Solution

More Details

Status
Completed
Sponsor
Kowa Research Institute, Inc.

Study Contact