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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03597139
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Voclosporin Ophthalmic Solution Drug: Restasis® Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Actual Study Start Date : August 17, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Voclosporin ophthalmic solution (VOS)
0.2% VOS, Twice Daily (BID), both eyes for 28 days
Drug: Voclosporin Ophthalmic Solution
Investigational Drug
Other Name: 0.2% VOS

Active Comparator: Comparator
0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days
Drug: Restasis®
Comparator
Other Name: RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%




Primary Outcome Measures :
  1. Drop Discomfort Assessment Visual Analogue Scale(VAS) [ Time Frame: 1-minute Post-Dose 1 instillation ]
    VAS scale 0 - 100 - Where 0 is the no discomfort and 100 the worst discomfort


Secondary Outcome Measures :
  1. Change from baseline in each of the 6 Individual Symptom Severity Assessments (Visual Analogue Scale) [ Time Frame: Day 7, 14 and 28 ]

    Burning/Stinging VAS - VAS scale 0 - 100, where 0 is no itching and 100 the worst itching

    Score: mm


  2. Change from baseline in Drop Discomfort [ Time Frame: Day 7, 14 and 28 ]

    Foreign body VAS - where 0 is no foreign body sensation and 100 worst foreign body sensation.

    Score: mm


  3. Change from baseline in Drop Discomfort [ Time Frame: Day 7, 14 and 28 ]

    Photofobia VAS - where 0 is no photophobia and 100 worst photophobia

    Score: mm


  4. Change from baseline in Drop Discomfort [ Time Frame: Day 7, 14 and 28 ]

    Eye Pain VAS - where 0 is no eye pain and 100 worst eye pain

    Score: mm


  5. Change from baseline in Drop Discomfort [ Time Frame: Day 7, 14 and 28 ]

    Eye Dryness VAS - where 0 is no eye dryness and 100 worst eye dryness

    Score: mm


  6. Change from baseline in Drop Discomfort [ Time Frame: Day 7, 14 and 28 ]

    Itching VAS - where 0 is no itching and 100 is worst itching

    Score: mm


  7. Change from baseline in the sum of the Individual Symptom Severity Assessments score (burning, body sensation, photophobia, eye pain, eye dryness and itching) [ Time Frame: Day 7 and 14 and 28 ]

    VAS Total Symptom Summary Score

    Sum score: mm


  8. Change from baseline in Symptom Assessment in Dry Eye Score (SANDE) [ Time Frame: Day 7, 14 and 28 ]

    SANDE Score - Frequency of Eye Dry Symptoms 100mm scale: 0 corresponds to rarely and 100mm corresponds to all the time

    • Severity of symptoms of Dry Eye where 0 corresponds to very mild and 100mm corresponds to Very Severe

    Score: mm


  9. Change from baseline in unanesthetized Schirmer Test Score ( Schirmer Test graduated strips from 0 to 35 mm) [ Time Frame: Day 14 and 28 ]
    <10 mm inadequate tear production

  10. Change from baseline in Fluorescein Corneal Staining (FCS) total score [ Time Frame: Day 7, 14 and 28 ]
    National Eye Institute (NEI)/Industry Workshop 0-15 scale A standardized grading system of 0-3 is used for each of the five areas of the cornea. The maximum score is 15. Grade 0 will be specified when no staining is present.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
  3. 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]).
  4. Have normal lid anatomy.

Exclusion Criteria:

  1. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
  2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
  3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
  4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
  5. Have used Restasis® for more than 1 month (if prior use is reported).
  6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
  7. Have had corneal graft surgery in either eye within 1 year.
  8. Have recent or current evidence of ocular infection or inflammation in either eye.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597139


Locations
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United States, California
Aurinia Investigative Center
Garden Grove, California, United States, 92843
Aurinia Investigative Center
Mission Hills, California, United States, 91345
Aurinia Investigative Center
Rancho Cordova, California, United States, 95670
United States, Missouri
Aurinia Investigative Center
Kansas City, Missouri, United States, 64111
Aurinia Investigative Center
Washington, Missouri, United States, 63090
United States, North Carolina
Aurinia Investigative Center
High Point, North Carolina, United States, 27262
United States, Tennessee
Aurinia Investigative Center
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.

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Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03597139     History of Changes
Other Study ID Numbers: AUR-VOS-2017-01
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aurinia Pharmaceuticals Inc.:
Dry Eye
Calcineurin Inhibitors

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Cyclosporins
Cyclosporine
Ophthalmic Solutions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors