Clinical Performance of a Silicone Hydrogel Following One Night of Extended Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Visual Acuity (VA) With Study Lenses, Collected by Eye
研究概览
简要总结
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.
详细描述
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Able to understand and sign an approved Informed Consent form.
- •Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality.
- •Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- •Current Biofinity® lens wearer.
- •Pregnant or breast-feeding.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Visual Acuity (VA) With Study Lenses, Collected by Eye
时间窗: Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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