Lotrafilcon B Plano Cosmetic Contact Lenses Post-Market Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Incidence of microbial keratitis
研究概览
简要总结
The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.
详细描述
Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of their participation in the study, approximately 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
- •Has never worn contact lenses before, with or without refractive error correction.
- •Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of lotrafilcon B plano cosmetic contact lenses.
- •Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
- •Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease or condition that would contraindicate contact lens wear.
- •Pregnant and lactating women.
- •Any use of systemic or ocular medications that would contraindicate contact lens wear.
- •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.
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