NCT02676258已完成不适用
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
详细描述
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.
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
- •Subject should have normal eyes and use no ocular medications
- •Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism
- •VA correctable to Log MAR 0.1 or better.
- •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
- •Subjects have history of allergies that would contraindicate "normal" contact lens wear.
- •Subjects 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.
- •Subjects have medications that would contraindicate contact lens wear.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •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.
研究组 & 干预措施
Si-Hy soft contact lens
Experimental
olifilon B daily disposable soft contact lens
干预措施: Si-Hy (olifilcon B) (Device)
Vistakon soft contact lens
Active Comparator
narafilcon A daily disposable soft contact lens
干预措施: Vistakon (narafilcon A) (Device)
结局指标
主要结局
Visual Acuity
时间窗: over all follow-up visits for 3 month study period
logMAR visual acuity (VA) over all visits.
次要结局
- Any Slit Lamp Finding > Grade 2(over all follow-up visits for the 3 month study period)
- Subjective Response to Comfort, symptoms and complaints(over all follow-up visits for the 3 month study period)
研究者
研究点 (1)
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