Conditions: Dry Eye Syndromes Keratoconjunctivitis Sicca
Keywords: Ocular Discomfort Pain Corticosteroid Hyperemia Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 909
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: KPI-121 0.25% Ophthalmic Suspension intervention 2: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document:
Prot_SAP_000.pdf: 
NCT02819284 
Study ID:  
KPI-121-C-007 (STRIDE 2)  
 
Study Title:  
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% 
Ophthalmic Suspension Compared to Vehicle in Subjects with Dry Eye Disease 
 
Date:  
06 Jul 2017