At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 182 enrolled
Drug / intervention
OC-01 (varenicline) nasal spray +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.
Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)
In Brief
A Phase 2 clinical trial evaluating OC-01 (varenicline) nasal spray and Placebo (vehicle) nasal spray for Dry Eye Disease. Completed, enrolled 182 participants across 3 sites.
Detailed Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartAug 2018
First PostedAug 2018
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 17, 2018
Enrollment StartAug 15, 2018
Primary CompletionSep 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.9 years ago
Interventions
OC-01 (varenicline) nasal spraydrug
OC-01 (varenicline) nasal spray
Placebo (vehicle) nasal spraydrug
Placebo