Evaluation of Reflex Tear Production
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in TMH immediately following stimulation
研究概览
简要总结
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).
详细描述
The primary analysis will assess the change from baseline (pre- versus immediately post-cotton swab nasal stimulation) in tear meniscus height (TMH) using optical coherence tomography (OCT). This study will consist of one visit on a single day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
- •Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
- •Corrected Visual Acuity (Snellen) 20/200 or better in both eyes.
- •Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
- •Able, as assessed by the investigator, and willing to follow study instructions.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
- •Use of artificial tears within 2 hours of the Study Visit.
- •History of ocular surgery within 1 year of the Study Visit.
- •Use of contact lenses in either eye within 7 days of the Study Visit.
- •Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
- •Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Change from baseline in TMH immediately following stimulation
时间窗: Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation
TMH (the distance between the line of reflection along the top of the tear prism to the edges of the eyelids) will be measured in millimeters using OCT, a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. TMH will be assessed prior to nasal stimulation and upon completion of nasal stimulation. Only one eye will be assessed by OCT.
次要结局
未报告次要终点