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

NCT04143841 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-21

No results posted yet for this study

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

Interventions

DEVICE

Viveye OMNS treatment

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

DEVICE

Viveye OMNS sham treatment

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

Sponsors & Collaborators

  • Epitech Mag Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2021-01-06
Completion
2021-01-06

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143841 on ClinicalTrials.gov