NCT06172881已完成不适用
Novel Multifocal Soft Contact Lens Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Distance Visual Acuity
研究概览
简要总结
A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give informed consent
- •Any racial or ethnic origin
- •18 - 40 years of age
- •Distance visual acuity with best corrected visual acuity of 20/25 with each eye
- •Habitual soft contact lens wearer with myopia
- •Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).
排除标准
- •Current or active ocular inflammation or infection as determined by the Investigator.
- •Astigmatism > 0.75 D in either eye
- •History of previous eye surgery
- •Demonstration or history of corneal ectasia or keratoconus.
- •Pregnant or lactating.
结局指标
主要结局
Distance Visual Acuity
时间窗: 1 day (This is a single visit study)
LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
次要结局
未报告次要终点
研究者
Jennifer Fogt
PI
Ohio State University
研究点 (2)
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