Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- questionnaire addressing subjective comfort and wear time
研究概览
简要总结
Comparison of different contact lens materials.
详细描述
This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing and able to sign the informed consent form
- •ages 18 years or older
- •Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
- •spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
- •astigmatic power equal to or less than 0.75 D
排除标准
- •eye injury or surgery within 3 months immediately prior to enrolment for this trial
- •pre-existing ocular irritation that would preclude contact lens fitting
- •currently enrolled in an ophthalmic clinical trial
- •evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses use of as determined by the investigator
- •any use of medications for which contact lens wear could be contradicted, as determined by the investigator
- •current extended-wear users (sleep-in overnight)
- •current monovision leans wearers
- •pregnant women and nursing mothers
- •best-corrected visual acuity worse than 6/9 (logMAR: +0.20; Snellen decimal: 0.63)
结局指标
主要结局
questionnaire addressing subjective comfort and wear time
时间窗: subjects will be followed-up for three months
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
limbal redness - ocular biomicroscopy
时间窗: subjects will be followed-up for three months
Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
corneal staining - ocular biomicroscopy
时间窗: subjects will be followed-up for three months
Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
次要结局
未报告次要终点