At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 230 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 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model
In Brief
A Phase 2 clinical trial evaluating Lifitegrast and Placebo for Dry Eye. Completed, enrolled 230 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartAug 2009
Primary CompletionFeb 2010
TodayJul 2026
First PostedJun 23, 2009
Enrollment StartAug 3, 2009
Primary CompletionFeb 18, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.0 years ago
Interventions
Lifitegrastdrug
Ophthalmic Solution
Placebodrug
Ophthalmic Solution