Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- End-of-day Comfort
研究概览
简要总结
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign written Informed Consent Document.
- •Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
- •Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
- •Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
- •Willing to wear study lenses for at least eight hours per day and at least five days per week.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Has not worn contact lenses before.
- •Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
- •Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
- •Ocular surgery/trauma within the last six months.
- •Topical ocular or systemic use of antibiotics within seven days of enrollment.
- •Pregnant or nursing women.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DAILIES TOTAL1, then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
干预措施: Delefilcon A contact lenses (Device)
DAILIES TOTAL1, then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
干预措施: Narafilcon A contact lenses (Device)
TRUEYE, then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
干预措施: Delefilcon A contact lenses (Device)
TRUEYE, then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
干预措施: Narafilcon A contact lenses (Device)
结局指标
主要结局
End-of-day Comfort
时间窗: Week 2
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
次要结局
未报告次要终点