Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 7
- 主要终点
- Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
研究概览
简要总结
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
详细描述
The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- •Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Habitual monovision or multifocal contact lens wearers.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
LID220365 (OD) / LID006961 (OS)
LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
干预措施: LID220365 contact lens (Device)
LID220365 (OD) / LID006961 (OS)
LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
干预措施: LID006961 contact lens (Device)
LID006961 (OD) / LID220365 (OS)
LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
干预措施: LID220365 contact lens (Device)
LID006961 (OD) / LID220365 (OS)
LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
干预措施: LID006961 contact lens (Device)
结局指标
主要结局
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
时间窗: Day 4
VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place 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.
次要结局
未报告次要终点