Clinical Evaluation of an Investigational Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Overall Comfort
研究概览
简要总结
The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Germany: Be of legal age.
- •USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
- •Sign Informed Consent.
- •Wear soft contact lenses for at least 3 months prior to the study.
- •Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within twelve weeks prior to enrollment.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in any clinical trial.
- •Regularly wear contact lenses on an extended/overnight basis.
- •Germany: pregnant or lactating.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Overall Comfort
时间窗: 4 weeks
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Vision Quality During the Day
时间窗: 4 weeks
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
时间窗: 4 weeks
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Dryness Throughout the Day
时间窗: 4 weeks
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Average Daily Wear Time
时间窗: 4 weeks
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
次要结局
- Lens Fit(4 weeks)
- Corrected Visual Acuity(4 weeks)
- Overall Satisfaction(4 weeks)