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

Dry Eye Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147650
• Other study ID #: AUR-VOS-2019-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 14, 2019
• Est. completion date: October 8, 2020

Study information

• Verified date: December 2021
• Source: Aurinia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: October 8, 2020
• Est. primary completion date: September 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• 0.05% Voclosporin Ophthalmic Solution (VOS)
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
• 0.10% VOS
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
• 0.20% VOS
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Locations

Country	Name	City	State
United States	Aurinia Investigative Center	Andover	Massachusetts
United States	Aurinia Investigative Center	Colorado Springs	Colorado
United States	Aurinia Investigative Center	Cranberry Township	Pennsylvania
United States	Aurinia Investigative Center	Lewiston	Maine
United States	Aurinia Investigative Center	Louisville	Kentucky
United States	Aurinia Investigative Center	Memphis	Tennessee
United States	Aurinia Investigative Center	Nashville	Tennessee
United States	Aurinia Investigative Center	Newport Beach	California
United States	Aurinia Investigative Center	Raynham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aurinia Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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