One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- corneal staining - ocular biomicroscopy
研究概览
简要总结
Comparison of different contact lens materials.
详细描述
This is a 1-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 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 ≤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 or use of the accessory solutions, 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 lens 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
corneal staining - ocular biomicroscopy
时间窗: subjects will be followed-up for one month
Assessed using slit lamp with white light, low-medium magnification. 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.
questionnaire addressing subjective comfort and wear time
时间窗: subjects will be followed-up for one month
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 one month
Assessed using slit lamp with white light, low-medium magnification. 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.
conjunctival redness - ocular biomicroscopy
时间窗: subjects will be followed-up for one month
Assessed using slit lamp with white light, low-medium magnification. 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