NCT06817785已完成不适用
Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
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
- 45
- 试验地点
- 2
- 主要终点
- Lens Comfort
研究概览
简要总结
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
详细描述
The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 18 years of age and have full legal capacity to volunteer;
- •Have understood and signed an information consent letter;
- •Are willing and able to maintain the appointment schedule;
- •Are an adapted soft contact lens wearer;
- •Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
- •Have a refraction with a cylinder component of no more than -1.00DC in each eye;
- •Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.
排除标准
- •Are participating in any concurrent clinical or research study;
- •Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
- •Have a systemic condition that would contraindicate contact lens use;
- •Are using any systemic or topical medications that would contraindicate contact lens use;
- •Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
- •Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).
研究组 & 干预措施
Lens 1 (ocufilcon D)
Experimental
All participants will wear lens 1 for 15 minutes (Period 1).
干预措施: Lens 1 (ocufilcon D) (Device)
Lens 2 (somofilcon A)
Experimental
All participants will wear lens 2 for 15 minutes (Period 2).
干预措施: Lens 2 (somofilcon A) (Device)
结局指标
主要结局
Lens Comfort
时间窗: Immediately after lens application
The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
次要结局
未报告次要终点
研究者
研究点 (2)
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