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

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)

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.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca; Dry Eye Syndrome
• Intervention / Treatment: Drug: 0.05% Voclosporin Ophthalmic Solution (VOS); Drug: 0.10% VOS; Drug: 0.20% VOS; Drug: Vehicle Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 508
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Aurinia Investigative Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Aurinia Investigative Center
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Aurinia Investigative Center
  • Maine
    • Lewiston, Maine, United States, 04240
      • Aurinia Investigative Center
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Aurinia Investigative Center
    • Raynham, Massachusetts, United States, 02767
      • Aurinia Investigative Center
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Aurinia Investigative Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Aurinia Investigative Center
    • Nashville, Tennessee, United States, 37205
      • Aurinia Investigative Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.05% Voclosporin Ophthalmic Solution (VOS); 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks	Drug: 0.05% Voclosporin Ophthalmic Solution (VOS); 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Experimental: 0.10% VOS; 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks	Drug: 0.10% VOS; 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Experimental: 0.20% VOS; 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks	Drug: 0.20% VOS; 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Placebo Comparator: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)	Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.	4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Eye Dryness	Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."	Value at 4 Weeks minus value at baseline

Collaborators and Investigators

• Sponsor: Aurinia Pharmaceuticals Inc.
• Investigators: Study Director: Mary Palmen, Aurinia Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): September 17, 2020
• Study Completion (Actual): October 8, 2020

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Dry Eye Calcineurin Inhibitors
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AUR-VOS-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No