Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical Soft Contact Lenses (Verofilcon A) and PRECISION1T™ for Astigmatism Contact Lenses (Verofilcon A)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- Incidence of Microbial Keratitis
研究概览
简要总结
The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.
详细描述
This study consists of a Baseline Visit and a Year 1 Visit.
The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.
The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an Institutional Review Board (IRB), unless appropriate consent waiver for the retrospective chart review is provided by the IRB.
- •Verofilcon A (sphere or toric) contact lens wear as described in the protocol.
- •Best corrected spectacle distance visual acuity (VA) 20/25 or better at baseline.
- •Healthy, non-diseased eyes, as determined/known by the Investigator.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease or condition that would contraindicate contact lens wear present at baseline.
- •Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Incidence of Microbial Keratitis
时间窗: Up to Year 1
Microbial keratitis is a sight-threatening infection of the cornea.
Distance Visual Acuity with Study Lenses at Year 1 Follow-Up
时间窗: Year 1
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Distance Visual Acuity with Study Lenses at Baseline
时间窗: Baseline
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Incidence of Corneal Infiltrative Events
时间窗: Up to Year 1
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
次要结局
未报告次要终点