drugset / Trial / NCT02813265

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

NCT02813265

Phase 3 Completed 918 enrolled Kala Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2016-06
Primary completion
2017-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Loteprednol Etabonate Other / unclassified 0.25 % Topical

Indications