NCT02252133已完成不适用
Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Success Rate of Lens Centration After 7 ± 2 Days of Wear
研究概览
简要总结
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent document.
- •Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
- •Symptoms of contact lens discomfort as defined by protocol.
- •Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
- •Cylinder, if present, less or equal to 0.75D in either eyes at Visit
- •Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit
- •Acceptable contact lens fit with both study contact lenses.
- •Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Currently wearing DT1 or 1DAVTE.
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- •Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
- •Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- •Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
- •History of herpetic keratitis, ocular surgery or irregular cornea.
- •Prior refractive surgery (e.g. LASIK, PRK, etc).
- •Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
- •Judged ineligible as a patient in this clinical study by the investigator.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Success Rate of Lens Centration After 7 ± 2 Days of Wear
时间窗: Day 7, each product
Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.
次要结局
未报告次要终点
研究者
研究点 (1)
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