Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
研究概览
简要总结
The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.
详细描述
Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 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
- Single (Participant)
入排标准
- 年龄范围
- 40 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 consent form (ICF) that has been approved by an Institutional Review Board (IRB);
- •Willing to stop wearing habitual contact lenses for the duration of study participation;
- •Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
- •History of refractive surgery, or plan to have refractive surgery during the study;
- •Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
- •Monovision contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
时间窗: Day 2 of each study lens type worn during the corresponding crossover period
VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified for this endpoint.
次要结局
未报告次要终点