Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease

Overview

The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.

Full Title of Study: “A Pilot Study to Evaluate the Safety and Effectiveness of the Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2020

Interventions

  • Device: Viveye OMNS treatment
    • The Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only
  • Device: Viveye OMNS sham treatment
    • The Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only

Arms, Groups and Cohorts

  • Active Comparator: Single treatment
    • A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye.
  • Sham Comparator: Single sham treatment
    • A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye.

Clinical Trial Outcome Measures

Primary Measures

  • Best corrected visual acuity (BCVA)
    • Time Frame: 12 weeks
    • Frequency of treatment related deterioration in BCVA
  • Intraocular Pressure (IOP)
    • Time Frame: 12 weeks
    • IOP results will be summarized descriptively. 95% confidence intervals for the difference between treatment arms at each visit will be presented, assuming t-distribution.
  • Slit lamp biomicroscopy
    • Time Frame: 12 weeks
    • The percent related to worsening in ocular pathological changes observed
  • Rate of device/treatment related adverse events
    • Time Frame: 12 weeks
    • Rate of device/treatment related Incidence of Adverse events (AE) will be presented in tabular form by seriousness, severity and relation to treatment
  • Fluorescein corneal staining
    • Time Frame: 12 weeks
    • Change from baseline in fluorescein corneal staining score (NEI Scale 0-15) per treatment arm and visit (lower scores mean a better outcome.)
  • Ocular discomfort questionnaires
    • Time Frame: 12 weeks
    • Change from baseline in ocular discomfort questionnaires (Standard Patient Evaluation of Eye Dryness – SPEED) per treatment arm and visit. score from 0 to 28, higher scores mean a worse outcome. (Reduction in SUM score = improvement)

Participating in This Clinical Trial

Inclusion Criteria

1. Males and females, 18-80 years old

2. Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted):

1. SPEED questionnaire score ≥ 10 or OSDI value of 33-100 (with no more than three responses of "not applicable") AND

2. Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND

3. Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment)

3. No contact lens wear for at least seven days prior to the Screening Visit and willingness to forego contact lens wear for the duration of the study;

4. Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;

5. Willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits).

Exclusion Criteria

1. Significant anterior blepharitis including signs of Demodex eyelid infection;

2. If the subject is using prescription dry eye ophthalmic drug such as Restasis (Cyclosporine A 0.05% ophthalmic emulsion), Xiidra (Lifitegrast), Cequa (Cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit;

3. Change in eye lubricant type usage in the last 1 month prior enrollment. Use of any device to manage DED within 1 month of Screening Visit;

4. Punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid;

5. Corneal transplant in either or both eyes;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Epitech Mag Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Liora Lempert, +972-54-7525151, liora.lempert@epitechmag.com

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