At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 123 enrolled
Drug / intervention
OC-01 0.1% 0.6 mg/ml +2 moredrug
Likely dose
OC-01 0.1% 0.6 mg/mlfrom 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.
Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
In Brief
A Phase 2 clinical trial evaluating OC-01 0.1% 0.6 mg/ml, OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml), and 1 other intervention for Dry Eye Disease. Completed, enrolled 123 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesMexico
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartFeb 2019
First PostedMar 2019
Primary CompletionJan 2020
TodayJul 2026
First PostedMar 13, 2019
Enrollment StartFeb 18, 2019
Primary CompletionJan 7, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.3 years ago
Interventions
OC-01 0.1% 0.6 mg/mldrug
OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)
OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)drug
OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)
placebo comparatorother
vehicle control