Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- conjunctival redness - ocular biomicroscopy
研究概览
简要总结
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
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
- 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
- 是
入选标准
- •Willing and able to sign the informed consent form
- •Aged ≥18 years old
- •Experienced wearer of rigid gas permeable contact lenses
- •Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
- •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)
- •Corneal astigmatism ≤2.00 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
- •Current wearers of multifocal contact lenses
- •Current wearers of toric contact lenses (front surface design)
- •Current wearers of astigmatic contact lenses (posterior surface design)
- •Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
- •Unacceptable fit of habitual lenses
- •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
conjunctival redness - ocular biomicroscopy
时间窗: subjects will be followed-up for one month
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 one month
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'.
次要结局
未报告次要终点