NCT03480906已完成不适用
An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Successful microtherapeutic administration to the ocular surface
研究概览
简要总结
This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
- •Willing to forego use of contact lenses during study period
- •Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
- •Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test
排除标准
- •Prior clinically significant ocular history or abnormal eye exam
- •Use of ocular medication within 30 days of screening
- •Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
- •History of drug or alcohol abuse within 1 year of screening
- •Lid squeezer
- •Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD
- •Participation in any interventional study of an investigational drug or device within 30 days of screening
研究组 & 干预措施
Microdose administration
Experimental
Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD
干预措施: Latanoprost (Drug)
Eyedrop administration
Active Comparator
Latanoprost ophthalmic solution administered as an eyedrop
干预措施: Latanoprost (Drug)
结局指标
主要结局
Successful microtherapeutic administration to the ocular surface
时间窗: Treatment Day 3
Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer
次要结局
未报告次要终点
研究者
研究点 (1)
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