Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

• Status: Completed
• Trial end date: 2020-10-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurinia Pharmaceuticals Inc.
• Treatments: Cyclosporine; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Be at least 18 years of age.

• Have a documented history of Dry Eye prior to Visit 1.

• Willing and able to follow protocol procedures and instructions.

Exclusion criteria:

• Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.

• Recent or current evidence of infection or inflammation in either eye.

• Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.

• Have used any investigational drug or device within 30 days prior to Visit 1.

• Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.

• Have worn contact lenses 24 hours prior to Visit 1.

• Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.

• Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.