NCT01423773已完成不适用
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
CIBA VISION2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Final Comfort
研究概览
简要总结
The purpose of this study was to compare the fit and comfort of two types of contact lenses.
详细描述
The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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
- •Be of legal age of consent and sign Informed Consent document.
- •Normal binocularity.
- •Be able to wear soft contact lenses.
- •Willing to comply with the wear and study visit schedule.
- •Spherical contact lens prescription within 0.50 diopter of the available lens powers.
- •Spectacle cylinder less than or equal to 1.50 diopter.
- •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 any clinical trial.
- •Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Final Comfort
时间窗: Day 2, Hour 10
Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").
次要结局
未报告次要终点
研究者
研究点 (2)
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