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

NCT03597139 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AUR-VOS-2017-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Dry Eye

Keywords

Dry Eye; Calcineurin Inhibitors

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1

  Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".

  1-minute Post Dose 1 installation (Day 1)

Secondary Outcomes (11)

• Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28

  Day 28

• Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28

  Day 28

• Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28

  28 days

• Change From Baseline in Photophobia Post Dose Instillation on Day 28

  28 days

• Change From Baseline in Eye Pain Post Dose Instillation on Day 28

  28 days

Study Arms (2)

Voclosporin ophthalmic solution (VOS)

EXPERIMENTAL

0.2% VOS, Twice Daily (BID), both eyes for 28 days

Drug: Voclosporin Ophthalmic Solution

Comparator

ACTIVE COMPARATOR

0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days

Drug: Restasis®

Interventions

Voclosporin Ophthalmic Solution DRUG

Investigational Drug

Also known as: 0.2% VOS

Voclosporin ophthalmic solution (VOS)

Restasis® DRUG

Comparator

Also known as: RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%

Comparator

Eligibility Criteria

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

You may qualify if:

• Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
• Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
• Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:
• A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
• An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
• Evidence of ocular surface staining (total fluorescein staining score of at least 3 \[0-15 scale\]).
• Have normal lid anatomy.

You may not qualify if:

• Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
• Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
• Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
• Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
• Have used Restasis® for more than 1 month (if prior use is reported).
• Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
• Have had corneal graft surgery in either eye within 1 year.
• Have recent or current evidence of ocular infection or inflammation in either eye.
• Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (7)

Aurinia Investigative Center

Garden Grove, California, 92843, United States

Location

Aurinia Investigative Center

Mission Hills, California, 91345, United States

Location

Aurinia Investigative Center

Rancho Cordova, California, 95670, United States

Location

Aurinia Investigative Center

Kansas City, Missouri, 64111, United States

Location

Aurinia Investigative Center

Washington, Missouri, 63090, United States

Location

Aurinia Investigative Center

High Point, North Carolina, 27262, United States

Location

Aurinia Investigative Center

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Mary Palmen
• Organization: Aurinia Pharmaceuticals

clinicaltrials@auriniapharma.com

1 (250) 744-2487

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: August 13, 2018
• Primary Completion: November 9, 2018
• Study Completion: December 13, 2018
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)