A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxyAqua Silicone Hydrogel Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Log MAR visual acuity (VA)
研究概览
简要总结
The objective of this study is to demonstrate that the OxyAqua silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
详细描述
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs from one hospital. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics:
- •No anterior segment infection, inflammation or abnormality.
- •No other active ocular or systemic disease that would contraindicate contact lens wear; and
- •No medications that would contraindicate contact lens wear.
- •VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
- •1.00 to -10.00 D myopia, astigmatism less than 2.00 D
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Provide signed and dated informed consent form.
排除标准
- •Have history of allergies that would contraindicate "normal" contact lens wear.
- •Have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I (such as cornea or interstitial edema).
- •Have medications that would contraindicate contact lens wear.
- •Have had any cornea surgery.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
- •Any active participation in another clinical trial within 30 days prior to this study.
- •The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
- •A history of papillary conjunctivitis that has interfered with contact lens wear.
- •No monocular or monovision fits.
- •Alcoholic or Drug Abused.
结局指标
主要结局
Log MAR visual acuity (VA)
时间窗: one month
the visual acuity corrected with contact lens could reach 0.1 or better
次要结局
- Any slit lamp findings > grade 2(over all follow-up visits for the 1 month)
- Subjective response to comfort, symptoms and complaints(over all follow-up visits for the 1 month)