North American Comfilcon A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Visual Performance (Visual Acuity)
研究概览
简要总结
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
详细描述
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 to 75 years (inclusive).
- •Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
- •At least occasional overnight wear in the last 12 months.
排除标准
- •1. Current participation in a contact lens or contact lens care product clinical trial.
结局指标
主要结局
Visual Performance (Visual Acuity)
时间窗: At the end of 2 hours of wear
Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA
Incidence of contact lens-related adverse events
时间窗: At the end of 2 hours of wear
Incidence of contact lens-related adverse events will be recorded from subjects
次要结局
未报告次要终点