At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 207 enrolled
Drug / intervention
Cyclosporine A +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, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease
In Brief
A Phase 2 clinical trial evaluating Cyclosporine A and Placebo for Dry Eye Syndromes. Completed, enrolled 207 participants across 4 sites.
Detailed Summary
The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionJul 2016
Study CompletionSep 2016
TodayJul 2026
First PostedDec 1, 2015
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.6 years ago
Interventions
Cyclosporine Adrug
topical ocular, eye drops
Placebodrug
topical ocular, eye drops