NCT01007916已完成不适用
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
CIBA VISION0 个研究点目标入组 50 人开始时间: 2009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
- 50
- 主要终点
- Comfort Upon Insertion
研究概览
简要总结
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
- •Wears lenses at least 5 days per week and at least 12 hours per day.
- •Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
- •Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
- •Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
- •Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- •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.
- •Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- •Currently sleeping in contact lenses for more than 6 consecutive nights.
- •Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Comfort Upon Insertion
时间窗: 4 weeks of wear
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
次要结局
未报告次要终点
研究者
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