Clinical Comparison of Two Daily Disposable Toric Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- Overall Vision
研究概览
简要总结
The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.
详细描述
This trial compared the performance of two commercialized daily disposable contact lenses in Germany.
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
- None
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.
- •Germany: Be of legal age.
- •Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within twelve weeks.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in an ophthalmic clinical trial.
- •Wears contact lenses overnight while sleeping.
- •Habitual daily disposable contact lens wearer.
- •Monovision correction during the study.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Overall Vision
时间窗: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
时间窗: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
时间窗: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Overall Satisfaction
时间窗: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
次要结局
- Ease of Selecting Final Lens Power(Day 0)