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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147650
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : July 30, 2020

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




Primary Outcome Measures :
  1. Proportion of subjects with a ≥10 mm increase from baseline in Schirmer Tear Test (STT) [ Time Frame: 4 Weeks ]
    Proportion of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye.


Secondary Outcome Measures :
  1. Change from baseline in Eye Dryness [ Time Frame: 4 Weeks ]
    Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥60mm. Eye Dryness Visual Analogue Scale (0%-100%). 0% corresponds to "no discomfort" and 100% corresponds to "maximal discomfort."



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.

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


Contacts
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Contact: Fernanda Rospide 250-744-2487 frospide@auriniapharma.com
Contact: Mary Palmen mpalmen@auriniapharma.com

Locations
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United States, California
Aurinia Investigative Center Not yet recruiting
Newport Beach, California, United States, 92663
United States, Kentucky
Aurinia Investigative Center Not yet recruiting
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Aurinia Investigative Center Recruiting
Andover, Massachusetts, United States, 01810
Aurinia Investigative Center Not yet recruiting
Raynham, Massachusetts, United States, 02767
United States, Tennessee
Aurinia Investigative Center Not yet recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
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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
Last Update Posted: November 4, 2019
Last Verified: October 2019
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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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Syndrome
Disease
Pathologic Processes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions