Air Optix Daily Wear Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 5
- 主要终点
- Distance visual acuity (VA) with study lenses
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, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily 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. The baseline visit will be 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 lenses was released. Subjects meeting the eligibility criteria will be enrolled in the study.
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 1 year in a daily wear modality, as determined by the Investigator;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
- •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
时间窗: Up to Year 1
The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam.
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.
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.
次要结局
未报告次要终点