Post-market Clinical Follow-up Study of Alcon TOTAL30® Spherical Contact Lenses (Lehfilcon A) and TOTAL30® for Astigmatism Contact Lenses (Lehfilcon A)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Distance visual acuity with study lenses at 1-year follow-up
研究概览
简要总结
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.
详细描述
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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review).
The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).
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
- •Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint;
- •Best corrected spectacle visual acuity (VA) 20/25 or better at baseline;
- •Healthy, non-diseased eyes;
- •Other protocol-specified inclusion criteria may apply.
- •Key Exclusion Criteria, as determined or known by the Investigator:
- •Any ocular disease or condition that would contraindicate contact lens wear present at baseline;
- •The use of systemic or ocular medications that would contraindicate contact lens wear at baseline;
- •Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation;
- •Other protocol-specified exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
Distance visual acuity with study lenses at 1-year follow-up
时间窗: Year 1
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
Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Incidence of microbial keratitis
时间窗: Up to Year 1
Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
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.
次要结局
未报告次要终点