NCT03418259已完成不适用
Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Ocular surface disease index, OSDI
研究概览
简要总结
The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.
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
- Double (Participant, Investigator)
盲法说明
Placebo device
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular surface disease index, OSDI > 12 points.
- •Non-invasive breakup time, NIBUT < 11 seconds.
排除标准
- •Ocular surface disease index, OSDI < 12 points.
- •Non-invasive breakup time, NIBUT > 11 seconds.
结局指标
主要结局
Ocular surface disease index, OSDI
时间窗: Change from Baseline Ocular surface disease index at two weeks.
12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Scale 0-100, normal value range 0-12.
次要结局
- Noninvasive breakup time, NIBUT(Change from Baseline Noninvasive breakup time at two weeks.)
- Tear (lacrimal) meniscus height(Change from Baseline Tear (lacrimal) meniscus height at two weeks.)
- Meibography(Change from Baseline Meibo scale value at two weeks.)
- Phenol Red Thread Test, PRT(Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.)
- Corneal staining with fluorescein(Change from Baseline Efron Grading Scale value at two weeks.)
- Lissamin green test(Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.)
研究者
Jan-Erik Juto
Principal Investigator, M.D., Ph.D.
Karolinska Institutet
研究点 (1)
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