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

Primary Purpose

Dry Eye Syndrome, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.05% Voclosporin Ophthalmic Solution (VOS)
0.10% VOS
0.20% VOS
Vehicle Ophthalmic Solution
Sponsored by
Aurinia Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Calcineurin Inhibitors, Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center
  • Aurinia Investigative Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

0.05% Voclosporin Ophthalmic Solution (VOS)

0.10% VOS

0.20% VOS

Vehicle Ophthalmic Solution

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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."

Full Information

First Posted
October 30, 2019
Last Updated
December 8, 2021
Sponsor
Aurinia Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04147650
Brief Title
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Acronym
AUDREY
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
September 17, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurinia Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Keratoconjunctivitis Sicca
Keywords
Dry Eye Calcineurin Inhibitors, Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double masked
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.05% Voclosporin Ophthalmic Solution (VOS)
Arm Type
Experimental
Arm Description
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Arm Title
0.10% VOS
Arm Type
Experimental
Arm Description
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Arm Title
0.20% VOS
Arm Type
Experimental
Arm Description
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
Intervention Type
Drug
Intervention Name(s)
0.05% Voclosporin Ophthalmic Solution (VOS)
Intervention Description
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Intervention Type
Drug
Intervention Name(s)
0.10% VOS
Intervention Description
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Intervention Type
Drug
Intervention Name(s)
0.20% VOS
Intervention Description
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
Primary Outcome Measure Information:
Title
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Eye Dryness
Description
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."
Time Frame
Value at 4 Weeks minus value at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Palmen
Organizational Affiliation
Aurinia Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Aurinia Investigative Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Aurinia Investigative Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Aurinia Investigative Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Aurinia Investigative Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Aurinia Investigative Center
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Aurinia Investigative Center
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Aurinia Investigative Center
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Aurinia Investigative Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Aurinia Investigative Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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