Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.
研究概览
简要总结
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).
详细描述
The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.
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
- None
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
- •existing contact lens wearer
- •read and signed statement of informed consent
- •has clear central cornea
- •requires spherical distance correction
排除标准
- •has worn RGP contact lenses within the last 30 days
- •is using any ocular medication
- •has had refractive surgery
- •has an infectious disease
- •is pregnant or lactating
- •is participating in another clinical research study
结局指标
主要结局
Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.
时间窗: 3 months
The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.
次要结局
未报告次要终点