Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
研究概览
简要总结
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
- •Astigmatism
- •Requires contact lenses
- •Best corrected visual acuity of 20/25 or better in each eye
- •Other protocol-specified inclusion criteria may apply
排除标准
- •Any eye condition that contraindicates contact lens wear, as determined by the Investigator
- •Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
- •Other protocol-specified exclusion criteria may apply
研究组 & 干预措施
AOHG toric, then AO toric
Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
干预措施: Lotrafilcon B toric contact lenses with HYDRAGLYDE (Device)
AOHG toric, then AO toric
Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
干预措施: Lotrafilcon B toric contact lenses (Device)
AO toric, then AOHG toric
Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
干预措施: Lotrafilcon B toric contact lenses with HYDRAGLYDE (Device)
AO toric, then AOHG toric
Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
干预措施: Lotrafilcon B toric contact lenses (Device)
结局指标
主要结局
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
时间窗: Day 1, 10 minutes after lens insertion, each product
Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
次要结局
未报告次要终点