At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 113 enrolled
Drug / intervention
OC-01 (varenicline) nasal spray 1.2 mg/ml +1 moredrug
Likely dose
OC-01 (varenicline) nasal spray 1.2 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.
A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)
In Brief
A Phase 2 clinical trial evaluating OC-01 (varenicline) nasal spray 1.2 mg/ml and Placebo (vehicle) nasal spray for Neurotrophic Keratopathy. Completed, enrolled 113 participants across 31 sites.
Detailed Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotrophic Keratopathy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartJun 2021
First PostedJul 2021
Primary CompletionJan 2023
Study CompletionApr 2023
TodayJul 2026
First PostedJul 12, 2021
Enrollment StartJun 17, 2021
Primary CompletionJan 27, 2023
Study CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.0 years ago
Interventions
OC-01 (varenicline) nasal spray 1.2 mg/mldrug
OC-01
Placebo (vehicle) nasal spraydrug
Placebo (vehicle)