Visual Performance Investigation of Two Toric Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Mean Ocular Coma Score at 5mm Pupil at Day 30
研究概览
简要总结
The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.
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
- •Sign informed consent;
- •Wears toric soft contact lenses;
- •Can be successfully fit with study lenses within the power ranges available;
- •Has cylinder of ≥ -0.75 diopter in both eyes;
- •Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
- •Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular condition that would contraindicate contact lens wear;
- •Use of medications for which contact lens wear could be contraindicated;
- •Monocular (only 1 eye with functional vision) or fit with 1 lens;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Requires presbyopic correction;
- •Use of rewetting/lubricating eye-drops more than twice a day;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AO for Astig / Biofinity Toric
Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
干预措施: Lotrafilcon B toric contact lens (Device)
AO for Astig / Biofinity Toric
Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
干预措施: Comfilcon A toric contact lens (Device)
Biofinity Toric / AO for Astig
Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
干预措施: Lotrafilcon B toric contact lens (Device)
Biofinity Toric / AO for Astig
Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
干预措施: Comfilcon A toric contact lens (Device)
结局指标
主要结局
Mean Ocular Coma Score at 5mm Pupil at Day 30
时间窗: Day 30
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.
次要结局
未报告次要终点