NCT02813265

Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 918 (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

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	KPI-121 0.25% Ophthalmic Suspension
DRUG	Vehicle of KPI-121 0.25% Ophthalmic Suspension

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-06-24
• Last updated: 2021-02-03
• Results posted: 2020-12-03

Locations

60 sites across 1 country: United States