DD T2 Daily Disposable Registration Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 7
- 主要终点
- Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
研究概览
简要总结
The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
详细描述
Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/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
- •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 20/25 or better in each eye.
- •Other protocol-specified inclusion criteria may apply.
- •Exclusion Criteria
- •Any current or prior wear experience with DT1 lenses.
- •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.
- •Other protocol-specified exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
DD T2
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
干预措施: verofilcon A contact lenses (Device)
DT 1
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
干预措施: delefilcon A contact lenses (Device)
结局指标
主要结局
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
时间窗: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
次要结局
未报告次要终点