NCT03488017已完成不适用
Evaluation of the Safety and Tolerability of an Ocular Coil
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline in terms of ocular irritation
研究概览
简要总结
The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.
详细描述
This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years old
- •Informed and having given informed consent
- •Willing and able to comply with scheduled visits and other study procedures
排除标准
- •Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
- •Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
- •Subjects using eye drops (during the study).
- •Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
- •Subjects who do not speak and/or write Dutch properly.
- •Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics
- •Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
研究组 & 干预措施
Placebo Ocular Coil (right eye)
Experimental
Right eye
干预措施: Ocular Coil (Device)
Placebo Ocular Coil (left eye)
Experimental
Left eye
干预措施: Ocular Coil (Device)
结局指标
主要结局
Change from baseline in terms of ocular irritation
时间窗: 28 days
Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.
次要结局
- Total time of Ocular Coil retention(28 days)
- Percentage of Participants in Each Response Category of Subject Comfort(28 days)
- Incidence of ocular adverse events(28 days)
研究者
研究点 (1)
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