drugset / Trial / NCT03597139

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

NCT03597139 ↗

Phase 2 Completed 100 enrolled Aurinia Pharmaceuticals Inc.
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

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 0.05 % Other
Subject Voclosporin Other / unclassified 0.2 % Other

Indications