NCT01446835已完成不适用
Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
CIBA VISION2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2011年10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
- 151
- 试验地点
- 2
- 主要终点
- Cosmetic Appearance Preference
研究概览
简要总结
The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.
详细描述
Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 30 years of age (inclusive).
- •If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.
- •Sign written Informed Consent.
- •Chinese, Japanese, or Korean descent.
- •Brown eye color.
- •Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •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 ophthalmic trial.
- •Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- •Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Cosmetic Appearance Preference
时间窗: After 20 minutes of wear
Participant will be asked on a questionnaire, "Which lens do you prefer for looking more natural?" Subject will record on the questionnaire, "Left lens," "Right lens," or "No preference."
次要结局
- Lens Centration(After insertion and before 20 minutes of wear)
研究者
研究点 (2)
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