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

NCT04143841 | Terminated DMC

• 1 other identifier: CLP-10003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Single treatment

ACTIVE COMPARATOR

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

Single sham treatment

SHAM COMPARATOR

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

Interventions

Viveye OMNS treatment DEVICE

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

Single treatment

Viveye OMNS sham treatment DEVICE

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

Single sham treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Epitech Mag Ltd.: lead

Study Sites (3)

E.Wolfson MC

Holon, 5822012, Israel

Location

SZMC

Jerusalem, 9103102, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 29, 2019
• Study Start: October 30, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

IL (3)