CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 711 enrolled
Drug / intervention
Lifitegrast +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02284516
NCT02284516Phase 3Completed

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

Shire·interventional·Posted Nov 6, 2014·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating Lifitegrast and Placebo for Dry Eye Disease. Completed, enrolled 711 participants across 41 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartNov 6, 2014
Primary CompletionOct 5, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago

Interventions

Lifitegrastdrug

Lifitegrast Ophthalmic Solution 5%, BID for 84 days

Placebodrug

Placebo to match active treatment, BID for 84 days