drugset / Trial / NCT03597139
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
RandomizedParallel-groupSingle-blindTreatment
Summary
Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).
Timeline
- Start
- 2018-08-13
- Primary completion
- 2018-11-09
- Completion
- 2018-12-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Voclosporin Ophthalmic Solution (VOS) vs Comparator; p = 0.1491; Mean Difference (Final Values) 4.6 (95% CI -1.7 to 10.9); ANCOVA NCT03597139 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 0.05 % | Other |
| Subject | Voclosporin | Other / unclassified | 0.2 % | Other |