Assessing Fitting Guides in Alcon Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 21
- 主要终点
- Mean Number of Trial Lenses Needed to Fit Each Eye
研究概览
简要总结
The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent;
- •Normal eyes;
- •Current full-time soft contact lens wearer needing presbyopia correction;
- •Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- •Eye conditions (past or present) as specified in the protocol;
- •Currently wearing Alcon multifocal (MF) contact lenses;
- •Only one eye with functional vision;
- •Contact lens wear in one eye only;
- •Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AOA MF
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
干预措施: Lotrafilcon B multifocal contact lenses (Device)
DACP MF
Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
干预措施: Nelfilcon A multifocal contact lenses (Device)
DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
干预措施: Delefilcon A multifocal contact lenses (Device)
结局指标
主要结局
Mean Number of Trial Lenses Needed to Fit Each Eye
时间窗: VIsit 1/Day 1
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
次要结局
未报告次要终点