A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Log MAR visual acuities
研究概览
简要总结
The objective of this study is to demonstrate that the OxySoft 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. 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
- •Subject should have normal eye and use no ocular medications
- •VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 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
- •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, slip lamp findings greater than grade I (such as cornea or interstitial edema).
- •Subjects have medications that would contraindicate contact lens wear.
- •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.
- •Any active participation in another clinical trial within 30 days prior to this study.
- •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.
- •Monocular or monovision fits
- •Alcoholic or Drug Abused.
研究组 & 干预措施
Oxysoft
olifilcon C, daily disposable soft contact lens, 1 month
干预措施: oxysoft (olifilcon C) (Device)
SiHy
olifilcon B, dialy disposable soft contact lens, 1 month
干预措施: Si-Hy (olifilcon B) (Device)
结局指标
主要结局
Log MAR visual acuities
时间窗: 1 month
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
次要结局
- slit lamp findings(1 month)