A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Dry Eye Disease
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 644
- Locations
- 50
- Primary Endpoint
- Change in EDS (VAS) From Baseline to Day 85
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Vehicle Solution
Intervention: Placebo
K-161
K-161 Ophthalmic Solution
Intervention: K-161
Outcomes
Primary Outcomes
Change in EDS (VAS) From Baseline to Day 85
Time Frame: Baseline to Day 85
* Eye Dryness Score (EDS) on Visual analog scale (VAS) * Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)
Time Frame: Baseline to Day 85
* Assessed by expanded National Eye Institute (NEI) scale * Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed) * Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.
Secondary Outcomes
- Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)(Baseline to Day 85)