NCT01233089已完成不适用
Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
CIBA VISION2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2010年9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
- 194
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between 8 and 16 years of age.
- •Has the permission of a parent/legal guardian.
- •Is willing and able to, or has a parent/legal guardian who is willing and able to help them, follow instructions and maintain the appointment schedule.
- •Has had an ocular examination in the last two years.
- •Has never worn contact lenses before.
- •Has clear corneas and no active ocular disease.
- •Can be successfully fit with the lenses to be used in the study.
- •Has 20/25 or better best corrected visual acuity in each eye.
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Has any ocular disease.
- •Has a systemic condition that may affect a study outcome variable.
- •Is using any systemic or topical medications that may affect ocular health.
- •Has ocular or systemic allergies that could interfere with contact lens wear.
- •Has any ocular pathology or condition that would affect the wearing of contact lenses.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Visual acuity
时间窗: 3 months
Ease of fit
时间窗: 1 week
A participant was deemed to be successfully fit if they could insert/remove, handle and maintain study lenses by the 1-week visit and continued in the study.
PREP score
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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