Dry Eye Syndromes Clinical Trial
— OMNSOfficial 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
Verified date | April 2021 |
Source | Epitech Mag Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | January 6, 2021 |
Est. primary completion date | January 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Israel | E.Wolfson MC | Holon | |
Israel | SZMC | Jerusalem | |
Israel | Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Epitech Mag Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best corrected visual acuity (BCVA) | Frequency of treatment related deterioration in BCVA | 12 weeks | |
Primary | 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 | |
Primary | Slit lamp biomicroscopy | The percent related to worsening in ocular pathological changes observed | 12 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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