A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use

Shire41 sites in 1 country711 target enrollmentNovember 6, 2014

Overview

Phase: Phase 3
Intervention: Lifitegrast
Conditions: Dry Eye Disease
Sponsor: Shire
Enrollment: 711
Locations: 41
Primary Endpoint: Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Status: Completed
Last Updated: 4 years ago

Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Registry

clinicaltrials.gov

Start Date

November 6, 2014

End Date

October 5, 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Patient-reported history of Dry Eye Disease in both eyes.
•Use of over the counter artificial tears within the past 30 days.
•A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
•Able and willing to comply with all study procedures.

•Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
•Unwilling to stop wearing contact lenses during the study.
•LASIK or other ocular surgical procedures within 12 months prior to or during the study.
•Use of prohibited medications
•Significant medical conditions that could affect the study parameters.