A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Meibomian Gland change in expressibility
研究概览
简要总结
Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.
详细描述
This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.
The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.
This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Sham device produces noise but no stimulation energy. Assessor does not know which device the subject received. The subject does not know which device he or she received
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 6hrs visual display terminal
- •OSDI > 13
- •One of: SChirmer < 10, One quadrant staining > 2, or Meibomian Gland expression <12
排除标准
- •Opinion of investigator that subject not be in the study
研究组 & 干预措施
Treatment
This arm will receive a function iTEAR
干预措施: iTEAR100 (Device)
Sham
This arm will receive sham treatment device
干预措施: iTEAR100 (Device)
结局指标
主要结局
Meibomian Gland change in expressibility
时间窗: 14 days
Change in gland expression from meibomian glands
Corneal Staining
时间窗: 14 days
Change in Staining of cornea
Basal tear output
时间窗: 14 days
Change in the basal output of tears
次要结局
- Safety(30 days)