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

NCT ID: NCT04147650

Last Updated: 2021-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-10-08

Brief Summary

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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

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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.

Conditions

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Dry Eye Syndrome Keratoconjunctivitis Sicca

Keywords

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Dry Eye Calcineurin Inhibitors Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double masked

Study Groups

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0.05% Voclosporin Ophthalmic Solution (VOS)

0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Group Type EXPERIMENTAL

0.05% Voclosporin Ophthalmic Solution (VOS)

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.10% VOS

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.20% VOS

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type DRUG

Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Interventions

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0.05% Voclosporin Ophthalmic Solution (VOS)

0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Intervention Type DRUG

0.10% VOS

0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Intervention Type DRUG

0.20% VOS

0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks

Intervention Type DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurinia Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Palmen

Role: STUDY_DIRECTOR

Aurinia Pharmaceuticals

Locations

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Aurinia Investigative Center

Newport Beach, California, United States

Site Status

Aurinia Investigative Center

Colorado Springs, Colorado, United States

Site Status

Aurinia Investigative Center

Louisville, Kentucky, United States

Site Status

Aurinia Investigative Center

Lewiston, Maine, United States

Site Status

Aurinia Investigative Center

Andover, Massachusetts, United States

Site Status

Aurinia Investigative Center

Raynham, Massachusetts, United States

Site Status

Aurinia Investigative Center

Cranberry Township, Pennsylvania, United States

Site Status

Aurinia Investigative Center

Memphis, Tennessee, United States

Site Status

Aurinia Investigative Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol: Version 1.0

View Document

Document Type: Study Protocol: Version 2.0

View Document

Document Type: Study Protocol: Version 3.0

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AUR-VOS-2019-01

Identifier Type: -

Identifier Source: org_study_id