NCT03616899

Safety and Efficacy of KPI-121 in Subjects With DED

A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 901 (actual)
• Sponsor: Kala Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Detailed description

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Conditions

• Kerato Conjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	KPI-121 Ophthalmic Suspension	KPI-121 Ophthalmic Suspension
DRUG	Vehicle	Vehicle for KPI-121 0.25% ophthalmic suspension

Timeline

• Start date: 2018-07-10
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2018-08-06
• Last updated: 2021-04-02
• Results posted: 2021-04-02

Locations

81 sites across 1 country: United States

Regulatory

• FDA-regulated drug study