CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 758 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.

Search/NCT04036292
NCT04036292Phase 3Completed
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Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)

Oyster Point Pharma, Inc.·interventional·Posted Jul 29, 2019·Updated Nov 22, 2021

In Brief

A Phase 3 clinical trial evaluating OC-01 (varenicline) nasal spray and Placebo (vehicle) nasal spray for Dry Eye Disease (DED). Completed, enrolled 758 participants across 22 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 (DED)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartJul 23, 2019
Primary CompletionApr 10, 2020
Study CompletionFeb 5, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.9 years ago

Interventions

OC-01 (varenicline) nasal spraydrug

OC-01 (varenicline) nasal spray

Placebo (vehicle) nasal spraydrug

Placebo (vehicle) nasal spray