NCT05700422

Nasal Spray Study in Sjogren's Dry Eye Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sjogren's Syndrome
• Dry Eye

Interventions

Type	Name	Description
DRUG	Varenicline Nasal Spray	OC-01 (varenicline solution) 0.03 mg nasal spray

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-01-26
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study