At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 588 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.
A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)
In Brief
A Phase 3 clinical trial evaluating Lifitegrast and Placebo for Keratoconjunctivitis Sicca and Dry Eye Disease. Completed, enrolled 588 participants across 13 sites.
Detailed Summary
The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca, Dry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartAug 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedAug 22, 2011
Enrollment StartAug 29, 2011
Primary CompletionApr 28, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.9 years ago
Interventions
Lifitegrastdrug
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Placebodrug
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks