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

NCT04147650 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AUR-VOS-2019-01
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 9

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.

Conditions

Dry Eye Syndrome; Keratoconjunctivitis Sicca

Keywords

Dry Eye Calcineurin Inhibitors; Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Eye Dryness

  Value at 4 Weeks minus value at baseline

Study Arms (4)

0.05% Voclosporin Ophthalmic Solution (VOS)

EXPERIMENTAL

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

Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)

0.10% VOS

EXPERIMENTAL

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

Drug: 0.10% VOS

0.20% VOS

EXPERIMENTAL

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

Drug: 0.20% VOS

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

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

Drug: Vehicle Ophthalmic Solution

Interventions

0.05% Voclosporin Ophthalmic Solution (VOS) DRUG

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

0.05% Voclosporin Ophthalmic Solution (VOS)

0.10% VOS DRUG

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

0.10% VOS

0.20% VOS DRUG

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

0.20% VOS

Vehicle Ophthalmic Solution DRUG

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

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (9)

Aurinia Investigative Center

Newport Beach, California, 92663, United States

Location

Aurinia Investigative Center

Colorado Springs, Colorado, 80907, United States

Location

Aurinia Investigative Center

Louisville, Kentucky, 40206, United States

Location

Aurinia Investigative Center

Lewiston, Maine, 04240, United States

Location

Aurinia Investigative Center

Andover, Massachusetts, 01810, United States

Location

Aurinia Investigative Center

Raynham, Massachusetts, 02767, United States

Location

Aurinia Investigative Center

Cranberry Township, Pennsylvania, 16066, United States

Location

Aurinia Investigative Center

Memphis, Tennessee, 38119, United States

Location

Aurinia Investigative Center

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Results Point of Contact

• Title: Clinical Trial Support
• Organization: Aurinia Pharmaceuticals

clinicaltrials@auriniapharma.com

(250) 744-2487

Study Officials

• Mary Palmen

  Aurinia Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: October 14, 2019
• Primary Completion: September 17, 2020
• Study Completion: October 8, 2020
• Last Updated: December 10, 2021
• Results First Posted: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)