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

NCT ID: NCT04143841

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2021-01-06

Brief 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.

Conditions

Dry Eye Syndromes; ATD; Sjogren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Viveye OMNS treatment

Intervention Type: DEVICE

The Viveye OMNS treatment ( \~30 min) will be applied once, during the treatment visit only

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.

Group Type: SHAM_COMPARATOR

Viveye OMNS sham treatment

Intervention Type: DEVICE

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

Interventions

Viveye OMNS treatment

The Viveye OMNS treatment ( \~30 min) will be applied once, during the treatment visit only

Intervention Type: DEVICE

Viveye OMNS sham treatment

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

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epitech Mag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

E.Wolfson MC

Holon, , Israel

SZMC

Jerusalem, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

CLP-10003

Identifier Type: -

Identifier Source: org_study_id