Air Optix® Night and Day® Aqua Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of corneal infiltrative events
研究概览
简要总结
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
详细描述
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.
The anticipated duration of the study is approximately 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Normal eyes, as determined by the Investigator
- •At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
- •Baseline and 1-year visit charts available
- •Other protocol-specified inclusion criteria may apply
- •Exclusion Criteria
- •Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline
- •Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
- •History of refractive surgery or irregular cornea
- •Other protocol-specified exclusion criteria may apply
排除标准
- 未提供
结局指标
主要结局
Incidence of corneal infiltrative events
时间窗: Up to Year 1
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
Distance visual acuity by eye
时间窗: Year 1
The subject's chart will be reviewed for distance visual acuity.
Incidence of microbial keratitis
时间窗: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
次要结局
未报告次要终点