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

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

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes; Sjogren's Syndrome; ATD
• Intervention / Treatment: Device: Viveye OMNS treatment; Device: Viveye OMNS sham treatment

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 5822012
    • E.Wolfson MC
  • Jerusalem, Israel, 9103102
    • SZMC
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Viveye OMNS treatment; The Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only
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.	Device: Viveye OMNS sham treatment; The Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Epitech Mag Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): January 6, 2021
• Study Completion (Actual): January 6, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: October 27, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: CLP-10003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No