At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 328 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 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
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 328 participants across 9 sites.
Detailed Summary
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionMay 2018
Study CompletionJun 2018
TodayJul 2026
First PostedSep 26, 2017
Enrollment StartOct 19, 2017
Primary CompletionMay 22, 2018
Study CompletionJun 20, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.8 years ago
Interventions
CyclASol topical ocular, eye dropsdrug
Cyclosporine A solution in vehicle
Vehicle topical ocular, eye dropsdrug
Vehicle