drugset / Trial / NCT03616899

Safety and Efficacy of KPI-121 in Subjects With DED

NCT03616899

Phase 3 Completed 901 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
2018-07-10
Primary completion
2020-02-05
Completion
2020-02-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Loteprednol Etabonate Other / unclassified 0.25 % Other

Indications