Evaluation of the Performance of Non-molded Soft Contact Lenses
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
详细描述
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.
排除标准
- •Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
结局指标
主要结局
Visual Acuity
时间窗: 9 month
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation
时间窗: baseline
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization
时间窗: 9 month
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
次要结局
未报告次要终点
