Clinical trial NCT04147650: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndrome
Keratoconjunctivitis Sicca
Keywords: Dry Eye Calcineurin Inhibitors
Dry Eye Disease
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
timeFrame: 4 Weeks
Secondary outcomes:
measure: Change From Baseline in Eye Dryness
timeFrame: Value at 4 Weeks minus value at baseline
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Aurinia Investigative Center
state: California
city: Colorado Springs
country: United States
facility: Aurinia Investigative Center
state: Colorado
city: Louisville
country: United States
facility: Aurinia Investigative Center
state: Kentucky
city: Lewiston
country: United States
facility: Aurinia Investigative Center
state: Maine
city: Andover
country: United States
facility: Aurinia Investigative Center
state: Massachusetts
city: Raynham
country: United States
facility: Aurinia Investigative Center
state: Massachusetts
city: Cranberry Township
country: United States
facility: Aurinia Investigative Center
state: Pennsylvania
city: Memphis
country: United States
facility: Aurinia Investigative Center
state: Tennessee
city: Nashville
country: United States
facility: Aurinia Investigative Center
state: Tennessee
Study officials:
affiliation: Aurinia Pharmaceuticals
name: Mary Palmen
role: STUDY_DIRECTOR
References: