Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Distance VA (logMAR) With Study Lenses
研究概览
简要总结
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
详细描述
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Sign Informed Consent document.
- •Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any eye condition or disease or use of medication that contraindicates contact lens wear.
- •Eye surgery, irregular cornea, eye injury as specified in the protocol.
- •Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- •Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- •Habitually wears Biofinity contact lenses.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
LID017569, then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Lehfilcon A contact lenses (Device)
LID017569, then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Comfilcon A contact lenses (Device)
LID017569, then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Multi-purpose disinfection solution (Device)
Biofinity, then LID017569
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Lehfilcon A contact lenses (Device)
Biofinity, then LID017569
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Comfilcon A contact lenses (Device)
Biofinity, then LID017569
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
干预措施: Multi-purpose disinfection solution (Device)
结局指标
主要结局
Distance VA (logMAR) With Study Lenses
时间窗: Day 30 after a minimum of 6 hours of wear, each product
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
次要结局
未报告次要终点