Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
研究概览
简要总结
The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent;
- •Adapted soft contact lens wearer;
- •Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
- •Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Currently wearing multifocal contact lenses;
- •Currently wearing monovision;
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications which could contraindicate contact lens wear;
- •Eye injury or surgery within 12 weeks prior to enrollment;
- •Prior refractive surgery;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DACP MF, then PROCLEAR 1D MF
DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
干预措施: DACP MF (Device)
DACP MF, then PROCLEAR 1D MF
DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
干预措施: PROCLEAR 1D MF (Device)
PROCLEAR 1D MF, then DACP MF
PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
干预措施: DACP MF (Device)
PROCLEAR 1D MF, then DACP MF
PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
干预措施: PROCLEAR 1D MF (Device)
结局指标
主要结局
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
时间窗: Day 5, each product
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
次要结局
- Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear(Day 5, each product)