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

Aurinia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Voclosporin Ophthalmic Solution; Drug: Restasis®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03597139

AUR-VOS-2017-01

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Have a documented history of DED in both eyes supported by a previous clinical diagnosis.

3. 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]).

4. Have normal lid anatomy.

Exclusion criteria

1. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
5. Have used Restasis® for more than 1 month (if prior use is reported).
6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
7. Have had corneal graft surgery in either eye within 1 year.
8. Have recent or current evidence of ocular infection or inflammation in either eye.
9. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Voclosporin ophthalmic solution (VOS)

Experimental group

Description:

0.2% VOS, Twice Daily (BID), both eyes for 28 days

Treatment:

Drug: Voclosporin Ophthalmic Solution

Comparator

Active Comparator group

Description:

0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days

Treatment:

Drug: Restasis®