CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 720 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/NCT01743729
NCT01743729Phase 3Completed

A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)

Shire·interventional·Posted Dec 6, 2012·Updated Jun 23, 2021

In Brief

A Phase 3 clinical trial evaluating Lifitegrast and Placebo for Dry Eye Disease. Completed, enrolled 720 participants across 31 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartDec 7, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.6 years ago

Interventions

Lifitegrastdrug

Lifitegrast Ophthalmic Solution 5.0%

Placebodrug

Placebo for Lifitegrast Ophthalmic Solution 5.0%