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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT04147650
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Dry Eye Syndrome
  • Keratoconjunctivitis Sicca

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 14, 2019
Status verified
Dec 2021
Primary completion
Sep 17, 2020
Completion
Oct 8, 2020

Study Design

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

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) [ Time Frame: 4 Weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Aurinia Investigative CenterNewport BeachCalifornia92663-
Aurinia Investigative CenterColorado SpringsColorado80907-
Aurinia Investigative CenterLouisvilleKentucky40206-
Aurinia Investigative CenterLewistonMaine04240-
Aurinia Investigative CenterAndoverMassachusetts01810-
Aurinia Investigative CenterRaynhamMassachusetts02767-
Aurinia Investigative CenterCranberry TownshipPennsylvania16066-
Aurinia Investigative CenterMemphisTennessee38119-
Aurinia Investigative CenterNashvilleTennessee37205-

Find similar trials in Newport Beach, CA

By research site
Aurinia Investigative Center· Newport Beach, CAAurinia Investigative Center· Colorado Springs, COAurinia Investigative Center· Louisville, KYAurinia Investigative Center· Lewiston, MEAurinia Investigative Center· Andover, MAAurinia Investigative Center· Raynham, MA

Related Studies