At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 232 enrolled
Drug / intervention
SI-614 +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 Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye
In Brief
A Phase 3 clinical trial evaluating SI-614 and Placebo for Dry Eye Disease. Completed, enrolled 232 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
CollaboratorsORA, Inc., Statistics & Data Corporation
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionMar 2023
Study CompletionApr 2023
TodayJul 2026
First PostedJun 9, 2022
Enrollment StartJul 28, 2022
Primary CompletionMar 2, 2023
Study CompletionApr 27, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.1 years ago
Interventions
SI-614drug
One drop of study drug was instilled in each eye 4 times daily for 84 days
Placebodrug
One drop of study drug was instilled in each eye 4 times daily for 84 days