Air Optix Extended Wear Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 4
- 主要终点
- Distance visual acuity (VA) with study lenses at Year 1
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 Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.
详细描述
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.
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
- •Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
- •Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
- •Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
- •Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;
- •Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance visual acuity (VA) with study lenses at Year 1
时间窗: Year 1
The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released.
Distance visual acuity (VA) with study lenses at Year 3
时间窗: Year 3
The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed.
Incidence of microbial keratitis
时间窗: Up to Year 3
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
Incidence of corneal infiltrative events
时间窗: Up to Year 3
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
次要结局
未报告次要终点