NCT03597139

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

An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

Detailed description

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Voclosporin Ophthalmic Solution	Investigational Drug
DRUG	Restasis®	Comparator

Timeline

• Start date: 2018-08-13
• Primary completion: 2018-11-09
• Completion: 2018-12-13
• First posted: 2018-07-24
• Last updated: 2021-07-08
• Results posted: 2021-07-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study