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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes, ATD, Sjogren's Syndrome

Intervention / Treatment
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* Device: Viveye OMNS treatment
* Device: Viveye OMNS sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18-80 years old Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted): SPEED questionnaire score ≥ 10 AND Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment) 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; Literacy, able to speak English or Hebrew, and able to complete questionnaires independently; 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: Significant anterior blepharitis including signs of Demodex eyelid infection; 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; 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; 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; Corneal transplant in either or both eyes;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single treatment<br>A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. | Device: Viveye OMNS treatment<br>* The Viveye OMNS treatment (  30 min) will be applied once, during the treatment visit only<br>|
| Sham Comparator: Single sham treatment<br>A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. | Device: Viveye OMNS sham treatment<br>* The Viveye OMNS sham treatment (  30 min) will be applied once, during the treatment visit only<br>|

What is the study measuring?
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Primary Outcome Measures

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