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

EpiTech Mag

Status: Terminated

Conditions: Sjogren's Syndrome; Dry Eye Syndromes; ATD

Treatments: Device: Viveye OMNS sham treatment; Device: Viveye OMNS treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04143841

CLP-10003

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Single treatment

Active Comparator group

Description:

A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye.

Treatment:

Device: Viveye OMNS treatment

Single sham treatment

Sham Comparator group

Description:

A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye.

Treatment:

Device: Viveye OMNS sham treatment