Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population
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.
研究组 & 干预措施
DT1, then 1DAVTE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
干预措施: Delefilcon A contact lenses (Device)
DT1, then 1DAVTE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
干预措施: Narafilcon A contact lenses (Device)
1DAVTE, then DT1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
干预措施: Delefilcon A contact lenses (Device)
1DAVTE, then DT1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
干预措施: Narafilcon A contact lenses (Device)
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