Multifocal Lens Design Evaluation (US)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Mean Binocular HC/HI Visual Acuity at Near (40 cm)
研究概览
简要总结
The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.
详细描述
Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Sign written Informed Consent document.
- •Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
- •Be presbyopic with a spectacle add ≥ 0.50 diopter.
- •Currently wearing soft contact lenses at least 5 days a week.
- •Other protocol-specified inclusion criteria may apply
排除标准
- •Eye injury or surgery within 12 weeks of enrollment in this trial.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in any clinical trial.
- •Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
- •Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
- •Binocular visual acuity worse than 20/
- •Corrected by monovision.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Binocular HC/HI Visual Acuity at Near (40 cm)
时间窗: Up to Hour 9
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
次要结局
- Mean Binocular HC/HI Visual Acuity at Distance(Up to Hour 9)
- Mean Monocular Over-refraction (OR) at Distance(Up to Hour 9)