CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
Varenicline Nasal Spraydrug
Likely dose
Varenicline Nasal Spray 0.03 mgfrom 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/NCT05700422
NCT05700422Phase 4Completed
CompareCT.gov

A Single-arm Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects With Sjogren's Syndrome

University of Pennsylvania·interventional·Posted Jan 26, 2023·Updated Nov 5, 2024

In Brief

A Phase 4 clinical trial evaluating Varenicline Nasal Spray for Sjogren's Syndrome and Dry Eye. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This study will investigate how well OC-01 (varenicline) nasal spray can treat the signs and symptoms of dry eye disease in those Sjogren's Syndrome. Patients at least 18 years old with moderate-to-severe Sjogren's dry eye disease may be eligible for this study. If you are eligible to participate in the study and you decide to join, there will be 3 study visits over approximately 1 month. You will also self-administer the nasal spray at home every day, 2 times a day during this month.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSjogren's Syndrome, Dry Eye
CountriesUnited States
CollaboratorsOyster Point Pharma, Inc.

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedJan 26, 2023
Enrollment StartMay 1, 2023
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.4 years ago

Interventions

Varenicline Nasal Spraydrug

OC-01 (varenicline solution) 0.03 mg nasal spray