Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- End of Day Comfort
研究概览
简要总结
The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.
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
- 41 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 41 to 68 (inclusive).
- •Spectacle add between +0.75 and +2.75D (inclusive).
- •Habitual spectacle prescription ≤ 1.00DC (cyl).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within twelve weeks of enrollment.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in a clinical trial.
- •Prior refractive surgery.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
End of Day Comfort
时间窗: 5 days of wear, lenses replaced daily
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
End of Day Dryness
时间窗: 5 days of wear, lenses replaced daily
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Handling at Removal
时间窗: 5 days of wear, lenses replaced daily
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Overall Vision
时间窗: 5 days of wear, lenses replaced daily
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
次要结局
- Overall Fit(Day 5, lenses replaced daily)