Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Part of paid clinical trials in Garden Grove, California.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT03597139
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

Key Dates

Start date
Aug 13, 2018
Status verified
May 2021
Primary completion
Nov 9, 2018
Completion
Dec 13, 2018

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Voclosporin ophthalmic solution (VOS)
    0.2% VOS, Twice Daily (BID), both eyes for 28 days
  • Active Comparator: Comparator
    0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days

Primary Outcome Measure

Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1 [ Time Frame: 1-minute Post Dose 1 installation (Day 1) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Aurinia Investigative CenterGarden GroveCalifornia92843-
Aurinia Investigative CenterMission HillsCalifornia91345-
Aurinia Investigative CenterRancho CordovaCalifornia95670-
Aurinia Investigative CenterKansas CityMissouri64111-
Aurinia Investigative CenterWashingtonMissouri63090-
Aurinia Investigative CenterHigh PointNorth Carolina27262-
Aurinia Investigative CenterMemphisTennessee38119-

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