Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 主要终点
- Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
研究概览
简要总结
The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 35 years of age.
- •Spectacle add of +0.50 to +2.50 diopters (inclusive).
- •Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
- •Able to be fit in both eyes with soft multifocal lenses in available powers.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within 12 weeks of enrollment in trial.
- •Currently enrolled in any clinical trial.
- •Astigmatism of 1.00 diopter or more.
- •Currently wearing excluded brands of multifocal lenses, as specified by protocol.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
时间窗: 1 week
The participant read a Snellen chart at a 20-foot equivalent distance 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 equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
时间窗: 1 week
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 equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
次要结局
未报告次要终点