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

Dry Eye Syndromes Clinical Trial

— OMNS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04143841
• Other study ID #: CLP-10003
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: January 6, 2021

Study information

• Verified date: April 2021
• Source: Epitech Mag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• ATD
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	E.Wolfson MC	Holon
Israel	SZMC	Jerusalem
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Epitech Mag Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (BCVA)	Frequency of treatment related deterioration in BCVA	12 weeks
Primary	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
Primary	Slit lamp biomicroscopy	The percent related to worsening in ocular pathological changes observed	12 weeks
Primary	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
Primary	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
Primary	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