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
- 330
- 主要终点
- Overall Comfort
研究概览
简要总结
The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable 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
- Single (Participant)
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 and HIPAA form.
- •Be current weekly/monthly replacement contact lens wearer.
- •Be willing to not sleep in contact lenses during the study period.
- •Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
- •Have best corrected visual acuity of at least 20/25 in each eye.
- •Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
- •Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Be a neophyte or current wearer of daily disposable lenses.
- •Require monovision correction or use multifocal contact lenses.
- •Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
- •Have a history of ocular surgery/trauma within the last 6 months.
- •Use topical ocular or systemic antibiotics within 7 days of enrollment.
- •Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
- •Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- •Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
- •Use re-wetting drops once or more per day.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Delefilcon A, then narafilcon B
Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
干预措施: Delefilcon A contact lenses (DAILIES TOTAL1®) (Device)
Delefilcon A, then narafilcon B
Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
干预措施: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) (Device)
Narafilcon B, then delefilcon A
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
干预措施: Delefilcon A contact lenses (DAILIES TOTAL1®) (Device)
Narafilcon B, then delefilcon A
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
干预措施: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) (Device)
结局指标
主要结局
Overall Comfort
时间窗: Day 8
Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
次要结局
- Overall Quality of Vision(Day 8)
- End of Day Comfort(Day 8)