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

Aurinia Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye Syndrome; Keratoconjunctivitis Sicca

Treatments: Drug: 0.10% VOS; Drug: 0.20% VOS; Drug: 0.05% Voclosporin Ophthalmic Solution (VOS); Drug: Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04147650

AUR-VOS-2019-01

Details and patient eligibility

About

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.

Full description

This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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508 participants in 4 patient groups, including a placebo group

0.05% Voclosporin Ophthalmic Solution (VOS)

Experimental group

Description:

0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Treatment:

Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)

0.10% VOS

Experimental group

Description:

0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Treatment:

Drug: 0.10% VOS

0.20% VOS

Experimental group

Description:

0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Treatment:

Drug: 0.20% VOS

Vehicle Ophthalmic Solution

Placebo Comparator group

Description:

Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Treatment:

Drug: Vehicle Ophthalmic Solution