ATD, Dry Eye Syndromes, Sjogren's Syndrome
Conditions
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.
Interventions
DEVICEViveye OMNS treatment
The Viveye OMNS treatment ( \ 30 min) will be applied once, during the treatment visit only
DEVICEViveye OMNS sham treatment
The Viveye OMNS sham treatment ( \ 30 min) will be applied once, during the treatment visit only
Sponsors
Epitech Mag Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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): 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity (BCVA) | 12 weeks | Frequency of treatment related deterioration in BCVA |
| 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. |
| Slit lamp biomicroscopy | 12 weeks | The percent related to worsening in ocular pathological changes observed |
| 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.) |
| 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) |
Countries
Israel
Outcome results
None listed