drugset / Trial / NCT03873246
Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).
Timeline
- Start
- 2019-02-18
- Primary completion
- 2020-01-07
- Completion
- 2020-01-07
Publications
- Hauswirth SG, Kabat AG, Hemphill M, Somaiya K, Hendrix LH, Gibson AA. Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease. J Comp Eff Res. 2023 Jun;12(6):e220215. doi: 10.57264/cer-2022-0215. Epub 2023 Apr 25.
- Quiroz-Mercado H, Hernandez-Quintela E, Chiu KH, Henry E, Nau JA. A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study. Ocul Surf. 2022 Apr;24:15-21. doi: 10.1016/j.jtos.2021.12.007. Epub 2021 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | OC-01 | Small molecule | 0.6 mg/ml | Intranasal |
| Comparator | OC-01 | Small molecule | 1.2 mg/ml | Intranasal |