Clinical Comparison of Toric Contact Lenses Fit Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Distance VA with study lenses
研究概览
简要总结
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
详细描述
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.
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, 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 toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
- •Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
- •Willing to stop wearing habitual contact lenses during in-office visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current spherical, monovision or multifocal lens wearer.
- •Protocol-specified biomicroscopy findings at screening.
- •Current or history of herpetic keratitis in either eye.
- •Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DT1fA/T30fA/AOHGfA/P1fA
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Delefilcon A toric soft contact lens (Device)
DT1fA/T30fA/AOHGfA/P1fA
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lehfilcon A toric soft contact lens (Device)
DT1fA/T30fA/AOHGfA/P1fA
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lotrafilcon B toric soft contact lens (Device)
DT1fA/T30fA/AOHGfA/P1fA
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Verofilcon A toric soft contact lens (Device)
T30fA/AOHGfA/P1fA/DT1fA
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Delefilcon A toric soft contact lens (Device)
T30fA/AOHGfA/P1fA/DT1fA
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lehfilcon A toric soft contact lens (Device)
T30fA/AOHGfA/P1fA/DT1fA
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lotrafilcon B toric soft contact lens (Device)
T30fA/AOHGfA/P1fA/DT1fA
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Verofilcon A toric soft contact lens (Device)
AOHGfA/P1fA/DT1fA/T30fA
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Delefilcon A toric soft contact lens (Device)
AOHGfA/P1fA/DT1fA/T30fA
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lehfilcon A toric soft contact lens (Device)
AOHGfA/P1fA/DT1fA/T30fA
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lotrafilcon B toric soft contact lens (Device)
AOHGfA/P1fA/DT1fA/T30fA
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Verofilcon A toric soft contact lens (Device)
P1fA/DT1fA/T30fA/AOHGfA
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Delefilcon A toric soft contact lens (Device)
P1fA/DT1fA/T30fA/AOHGfA
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lehfilcon A toric soft contact lens (Device)
P1fA/DT1fA/T30fA/AOHGfA
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Lotrafilcon B toric soft contact lens (Device)
P1fA/DT1fA/T30fA/AOHGfA
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
干预措施: Verofilcon A toric soft contact lens (Device)
结局指标
主要结局
Distance VA with study lenses
时间窗: 30 mins (± 15 mins), each product
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
次要结局
未报告次要终点