NCT04942925已完成不适用
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 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 evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.
详细描述
The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.
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
- •Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
- •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.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current/previous PRECISION1 or INFUSE contact lens wearer.
- •Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
- •Routinely sleeps in contact lenses.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance VA (logMAR) With Study Lenses
时间窗: Day 8 (-0/+3 days), each study lens type
Distance visual acuity (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 inferential testing was pre-specified for this endpoint.
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Clinical Comparison of Two Daily Disposable Contact LensesRefractive ErrorsNCT04865354Alcon Research170
已完成
不适用
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2Refractive ErrorsMyopiaNCT04528017Alcon Research56
已完成
不适用
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1Refractive ErrorsMyopiaNCT04527978Alcon Research56
已完成
不适用
Clinical Performance of Two Daily Disposable Soft Contact LensesRefractive ErrorsNCT05138783Alcon Research129
已完成
不适用
Clinical Comparison of Two Daily Disposable Soft Contact LensesRefractive ErrorsMyopiaNCT03518008Alcon Research22