At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 332 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 Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)
In Brief
A Phase 3 clinical trial evaluating Lifitegrast and Placebo for Dry Eye Disease. Completed, enrolled 332 participants across 23 sites.
Detailed Summary
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartOct 2012
Primary CompletionMar 2014
TodayJul 2026
First PostedJul 10, 2012
Enrollment StartOct 16, 2012
Primary CompletionMar 3, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.0 years ago
Interventions
Lifitegrastdrug
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year
Placebodrug
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year