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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147650
Recruitment Status : Completed
First Posted : November 1, 2019
Results First Posted : December 10, 2021
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Keratoconjunctivitis Sicca Drug: 0.05% Voclosporin Ophthalmic Solution (VOS) Drug: 0.10% VOS Drug: 0.20% VOS Drug: Vehicle Ophthalmic Solution Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
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.
Masking: Double (Participant, Investigator)
Masking Description: Double masked
Primary Purpose: Treatment
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)
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : September 17, 2020
Actual Study Completion Date : October 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Voclosporin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) [ Time Frame: 4 Weeks ]
    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 :
  1. Change From Baseline in Eye Dryness [ Time Frame: Value at 4 Weeks minus value at baseline ]
    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."


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147650


Locations
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United States, California
Aurinia Investigative Center
Newport Beach, California, United States, 92663
United States, Colorado
Aurinia Investigative Center
Colorado Springs, Colorado, United States, 80907
United States, Kentucky
Aurinia Investigative Center
Louisville, Kentucky, United States, 40206
United States, Maine
Aurinia Investigative Center
Lewiston, Maine, United States, 04240
United States, Massachusetts
Aurinia Investigative Center
Andover, Massachusetts, United States, 01810
Aurinia Investigative Center
Raynham, Massachusetts, United States, 02767
United States, Pennsylvania
Aurinia Investigative Center
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Aurinia Investigative Center
Memphis, Tennessee, United States, 38119
Aurinia Investigative Center
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
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Study Director: Mary Palmen Aurinia Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Aurinia Pharmaceuticals Inc.:
Study Protocol: Version 1.0  [PDF] July 26, 2019
Study Protocol: Version 2.0  [PDF] September 4, 2019
Study Protocol: Version 3.0  [PDF] June 26, 2020
Statistical Analysis Plan  [PDF] June 26, 2020

More Information
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Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04147650    
Other Study ID Numbers: AUR-VOS-2019-01
First Posted: November 1, 2019    Key Record Dates
Results First Posted: December 10, 2021
Last Update Posted: December 10, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurinia Pharmaceuticals Inc.:
Dry Eye Calcineurin Inhibitors
Dry Eye Disease
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
 Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions