CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
OC-01 Low Dose, 0.12 mg/mL +3 moredrug
Likely dose
OC-01 Low Dose, 0.12 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.

Search/NCT03920215
NCT03920215Phase 3Completed
CompareCT.gov

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 Study)-Long Term Safety Follow-up

Oyster Point Pharma, Inc.·interventional·Posted Apr 18, 2019·Updated Nov 1, 2023

In Brief

A Phase 3 clinical trial evaluating OC-01 Low Dose, 0.12 mg/mL, OC-01 Mid Dose, 0.6 mg/mL, and 2 other interventions for Long Term Follow up Dry Eye Disease. Completed, enrolled 101 participants across 3 sites.

Detailed Summary

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLong Term Follow up Dry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartAug 15, 2018
Primary CompletionSep 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.2 years ago

Interventions

OC-01 Low Dose, 0.12 mg/mLdrug

OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mLdrug

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mLdrug

OC-01 (varenicline) nasal spray

Placebo (vehicle) nasal spraydrug

Placebo (vehicle) nasal spray