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

A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)

Sponsors

Lead Sponsor: Aurinia Pharmaceuticals Inc.

Source Aurinia Pharmaceuticals Inc.
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date October 14, 2019
Completion Date July 30, 2020
Primary Completion Date May 30, 2020
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of subjects with a ≥10 mm increase from baseline in Schirmer Tear Test (STT) 4 Weeks
Secondary Outcome
Measure Time Frame
Change from baseline in Eye Dryness 4 Weeks
Enrollment 480
Condition
Intervention

Intervention Type: Drug

Intervention Name: 0.05% Voclosporin Ophthalmic Solution (VOS)

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

Arm Group Label: 0.05% Voclosporin Ophthalmic Solution (VOS)

Intervention Type: Drug

Intervention Name: 0.10% VOS

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

Arm Group Label: 0.10% VOS

Intervention Type: Drug

Intervention Name: 0.20% VOS

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

Arm Group Label: 0.20% VOS

Intervention Type: Drug

Intervention Name: Vehicle Ophthalmic Solution

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

Arm Group Label: Vehicle Ophthalmic Solution

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Fernanda Rospide

Phone: 250-744-2487

Email: [email protected]

Location
Facility: Status:
Aurinia Investigative Center | Newport Beach, California, 92663, United States Not yet recruiting
Aurinia Investigative Center | Louisville, Kentucky, 40206, United States Not yet recruiting
Aurinia Investigative Center | Andover, Massachusetts, 01810, United States Recruiting
Aurinia Investigative Center | Raynham, Massachusetts, 02767, United States Not yet recruiting
Aurinia Investigative Center | Memphis, Tennessee, 38119, United States Not yet recruiting
Location Countries

United States

Verification Date

October 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 0.05% Voclosporin Ophthalmic Solution (VOS)

Type: Experimental

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

Label: 0.10% VOS

Type: Experimental

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

Label: 0.20% VOS

Type: Experimental

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

Label: Vehicle Ophthalmic Solution

Type: Placebo Comparator

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

Acronym AUDREY
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Subjects will be randomized to one of the following treatment groups: Investigational product (IP): one drop 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks, one drop 0.10% VOS OU BID over 12 weeks, or one drop 0.20% VOS OU BID over 12 weeks. Comparator: one drop VOS vehicle OU BID over 12 weeks.

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Masking Description: Double masked

Source: ClinicalTrials.gov