Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- Distance Visual Acuity (VA) With Study Lenses
研究概览
简要总结
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
详细描述
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
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
- 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
- •Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
- •Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular condition that contraindicates contact lens wear.
- •Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Distance Visual Acuity (VA) With Study Lenses
时间窗: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
次要结局
未报告次要终点