A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.
详细描述
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
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
- Double (Participant, Investigator)
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 -1.25 D astigmatism
- •VA correctable to 20/25 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 solution use and/or "normal" contact lens wear.
- •Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test < 5mm/5min or other physical condition that would contraindicate contact lens wear.
- •Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
- •Subjects have medications that would contraindicate contact lens wear.
- •Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
- •Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
- •Individuals participating in other clinical studies.
结局指标
主要结局
Visual Acuity
时间窗: 3 months
Visual acuity correctable to snellen 20/25 or better
次要结局
- Slit Lamp Findings(3 month)
- Symptoms, Problems and Complaints and Incidence Rate(3 month)