Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
研究概览
简要总结
The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.
详细描述
Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles. Subjects were expected to attend 1 or 2 office visits. This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.
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)
盲法说明
This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
入排标准
- 年龄范围
- 38 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal eyes, other than correction for refractive error;
- •Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
- •Wears habitual correction at least 5 days per week and at least 6 hours per day.
排除标准
- •Monocular subjects;
- •Subjects fit with only one contact lens;
- •Known pregnancy or lactating;
- •History of or planned refractive surgery or irregular cornea in either eye.
- •Other protocol-specified inclusion and/or exclusion criteria may apply.
研究组 & 干预措施
Multifocal Contact Lenses
Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
干预措施: Multifocal soft contact lenses (Device)
PAL Spectacles
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
干预措施: Progressive addition lens spectacles (Other)
结局指标
主要结局
Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
时间窗: Day 1, after up to 3 hours of wear
The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.
次要结局
未报告次要终点