Trials / Completed
CompletedNCT05378945
Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease
A Phase 3, Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Chinese Population
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (actual)
- Sponsor
- Corxel Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Varenicline Tartrate Nasal Spray | Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days |
| DRUG | Placebo (vehicle) | Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days |
Timeline
- Start date
- 2022-07-22
- Primary completion
- 2023-04-04
- Completion
- 2023-04-04
- First posted
- 2022-05-18
- Last updated
- 2023-04-25
Locations
20 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05378945. Inclusion in this directory is not an endorsement.