Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
- Conditions
- ATDSjogren's SyndromeDry Eye Syndromes
- Interventions
- Device: Viveye OMNS sham treatmentDevice: Viveye OMNS treatment
- Registration Number
- NCT04143841
- Lead Sponsor
- Epitech Mag Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
-
Males and females, 18-80 years old
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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).
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single sham treatment Viveye OMNS 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. Single treatment Viveye OMNS treatment A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye.
- Primary Outcome Measures
Name Time Method Slit lamp biomicroscopy 12 weeks The percent related to worsening in ocular pathological changes observed
Ocular discomfort questionnaires 12 weeks 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)
Intraocular Pressure (IOP) 12 weeks IOP results will be summarized descriptively. 95% confidence intervals for the difference between treatment arms at each visit will be presented, assuming t-distribution.
Best corrected visual acuity (BCVA) 12 weeks Frequency of treatment related deterioration in BCVA
Rate of device/treatment related adverse events 12 weeks Rate of device/treatment related Incidence of Adverse events (AE) will be presented in tabular form by seriousness, severity and relation to treatment
Fluorescein corneal staining 12 weeks Change from baseline in fluorescein corneal staining score (NEI Scale 0-15) per treatment arm and visit (lower scores mean a better outcome.)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
E.Wolfson MC
🇮🇱Holon, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
SZMC
🇮🇱Jerusalem, Israel