2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Normalized logMAR Visual Acuity
研究概览
简要总结
The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra 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 (Participant, Investigator)
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
- •Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Have no active ocular disease or allergic conjunctivitis.
- •Not be using any topical ocular medications.
- •Be willing and able to follow instructions.
- •Have signed a statement of informed consent.
排除标准
- •Participating in a conflicting study in the opinion of the Investigator.
- •Considered by the Investigator to not be a suitable candidate for participation.
研究组 & 干预措施
Samfilcon A Lenses with EPG01 Packaging Solution
Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution
干预措施: samfilcon A Lenses with EPG01 Packaging Solution (Device)
Commercially Available B+L Ultra Lenses
Subjects implanted with Commercially Available B+L Ultra Lenses
干预措施: Commercially Available B+L Ultra Lenses (Device)
结局指标
主要结局
Normalized logMAR Visual Acuity
时间窗: Assessed at 2-hour post-baseline
Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.
次要结局
未报告次要终点