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

• Sponsor: Epitech Mag Ltd. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04143841
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arms: 2
• Actual Duration (Months): 14.3
• Patients Per Site: 16.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; ATD; Sjogren's Syndrome	Device: Viveye OMNS treatment; Device: Viveye OMNS sham treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Evaluate the Safety and Effectiveness of the Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
• Actual Study Start Date: Oct 30, 2019
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Viveye OMNS treatment; The Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only
Sham Comparator: 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.	Device: Viveye OMNS sham treatment; The Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only

Outcome Measures

Primary Outcome Measures

1. Best corrected visual acuity (BCVA) [12 weeks]

   Frequency of treatment related deterioration in BCVA

2. 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.

3. Slit lamp biomicroscopy [12 weeks]

   The percent related to worsening in ocular pathological changes observed

4. 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

5. 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.)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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):

3. SPEED questionnaire score ≥ 10 AND

4. Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND

5. Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment)

6. 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;

7. Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;

8. 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E.Wolfson MC	Holon		Israel	5822012
2	SZMC	Jerusalem		Israel	9103102
3	Sourasky Medical Center	Tel Aviv		Israel	6423906

Sponsors and Collaborators

• Epitech Mag Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Epitech Mag Ltd.
• ClinicalTrials.gov Identifier: NCT04143841
• Other Study ID Numbers: CLP-10003
• First Posted: Oct 29, 2019
• Last Update Posted: Apr 21, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Syndrome

Study Results

No Results Posted as of Apr 21, 2021