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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Slit lamp biomicroscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18-80 years old
- •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).
排除标准
- •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;
结局指标
主要结局
Slit lamp biomicroscopy
时间窗: 12 weeks
The percent related to worsening in ocular pathological changes observed
Ocular discomfort questionnaires
时间窗: 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)
时间窗: 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)
时间窗: 12 weeks
Frequency of treatment related deterioration in BCVA
Rate of device/treatment related adverse events
时间窗: 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
时间窗: 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.)
次要结局
未报告次要终点