Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Summary
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
Timeline
- Start
- 2019-10-14
- Primary completion
- 2020-09-17
- Completion
- 2020-10-08
Outcome
Missed primary endpoint
registry analysis (superiority test); 0.05% Voclosporin Ophthalmic Solution (VOS); p = 0.1352; Odds Ratio (OR) 2.18 (95% CI 0.62 to 7.62); Regression, Logistic NCT04147650 ↗
registry analysis (superiority test); 0.10% VOS; p = 0.2823; Odds Ratio (OR) 1.78 (95% CI 0.49 to 6.45); Regression, Logistic NCT04147650 ↗
registry analysis (superiority test); 0.20% VOS; p = 0.0889; Odds Ratio (OR) 2.41 (95% CI 0.70 to 8.30); Regression, Logistic NCT04147650 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Voclosporin | Other / unclassified | 0.05 % | Topical |
| Subject | Voclosporin | Other / unclassified | 0.1 % | Topical |
| Subject | Voclosporin | Other / unclassified | 0.2 % | Topical |