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

Completed · Phase 2

Conditions studied: Dry Eye

In brief

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

Key facts

Study ID

NCT03597139

Run by

Aurinia Pharmaceuticals Inc.

People needed

100

Starts

2018-08-13

Expected to finish

2018-12-13

Last updated by the study team

2021-07-08

Who can join

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

You may qualify if…

• Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
• Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
• Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:
• A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
• An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
• Evidence of ocular surface staining (total fluorescein staining score of at least 3 [0-15 scale]).
• Have normal lid anatomy.

You may not qualify if…

• Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
• Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
• Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
• Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
• Have used Restasis® for more than 1 month (if prior use is reported).
• Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
• Have had corneal graft surgery in either eye within 1 year.
• Have recent or current evidence of ocular infection or inflammation in either eye.
• Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.

Where it is running

• Aurinia Investigative Center — Garden Grove, California, United States
• Aurinia Investigative Center — Mission Hills, California, United States
• Aurinia Investigative Center — Rancho Cordova, California, United States
• Aurinia Investigative Center — Kansas City, Missouri, United States
• Aurinia Investigative Center — Washington, Missouri, United States
• Aurinia Investigative Center — High Point, North Carolina, United States
• Aurinia Investigative Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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