Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- End of day (EOD) visual acuity at distance
研究概览
简要总结
The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.
详细描述
The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Able to understand and sign an approved Informed Consent form
- •Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
- •Best corrected VA of logMAR 0.10 or better in each eye
- •Willing to discontinue artificial tears and rewetting drops during the study
- •Able to wear contact lenses within the protocol-specified sphere power range
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
- •History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
- •Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Sequence 1
Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
干预措施: Verofilcon A contact lenses (Device)
Sequence 1
Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
干预措施: Etafilcon A contact lenses (Device)
Sequence 2
Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
干预措施: Verofilcon A contact lenses (Device)
Sequence 2
Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
干预措施: Etafilcon A contact lenses (Device)
结局指标
主要结局
End of day (EOD) visual acuity at distance
时间窗: Day 1, after 8 hours of wear
Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.
次要结局
未报告次要终点