NCT01630291已完成不适用
A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Schirmer Score
研究概览
简要总结
The purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe Dry Eye.
详细描述
A non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe Dry Eye Disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye
- •Sum of corneal and interpalpebral conjunctival staining of > +5 in the same eye where corneal staining is > +2 using the CLEK criteria.
排除标准
- •Individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. Individuals who have had LASIK or other refractive surgeries are eligible. Excluded conditions include:
- •History of orbital trauma
- •History of orbital surgery
- •Orbital cancer
- •History of orbital cancer
- •Within the 3 months before the Screening Visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes
结局指标
主要结局
Schirmer Score
时间窗: Up to 16 days
次要结局
未报告次要终点
研究者
研究点 (1)
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