At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 834 enrolled
Drug / intervention
CyclASol topical ocular, eye drops +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, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease
In Brief
A Phase 3 clinical trial evaluating CyclASol topical ocular, eye drops and Vehicle topical ocular, eye drops for Dry Eye Disease. Completed, enrolled 834 participants across 27 sites.
Detailed Summary
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartDec 2020
Primary CompletionSep 2021
Study CompletionOct 2021
TodayJul 2026
First PostedAug 21, 2020
Enrollment StartDec 5, 2020
Primary CompletionSep 3, 2021
Study CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.9 years ago
Interventions
CyclASol topical ocular, eye dropsdrug
Cyclosporine A solution in vehicle
Vehicle topical ocular, eye dropsdrug
Vehicle