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

Completed · Phase 2/Phase 3

Conditions studied: Dry Eye Syndrome, Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT04147650

Run by

Aurinia Pharmaceuticals Inc.

People needed

508

Starts

2019-10-14

Expected to finish

2020-10-08

Last updated by the study team

2021-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aurinia Investigative Center — Newport Beach, California, United States
• Aurinia Investigative Center — Colorado Springs, Colorado, United States
• Aurinia Investigative Center — Louisville, Kentucky, United States
• Aurinia Investigative Center — Lewiston, Maine, United States
• Aurinia Investigative Center — Andover, Massachusetts, United States
• Aurinia Investigative Center — Raynham, Massachusetts, United States
• Aurinia Investigative Center — Cranberry Township, Pennsylvania, United States
• Aurinia Investigative Center — Memphis, Tennessee, United States
• Aurinia Investigative Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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