NCT06785194尚未招募不适用
Samfilcon B Custom Toric Lens Real-World Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Investigator overall satisfaction as assessed by the Investigator Survey
研究概览
简要总结
This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 ICF is signed
- •Have the 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
- •Be an experienced soft contact lens wearer (have previously used soft contact lenses)
- •Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device
排除标准
- •Is participating in another research study
- •Is considered by the Investigator to not be a suitable candidate for participation
- •Is not eligible for treatment with the study lens per the IFU (contraindicated)
- •Has had previous ocular surgery
- •Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance
结局指标
主要结局
Investigator overall satisfaction as assessed by the Investigator Survey
时间窗: Assessed 14 days ± 3 days after the final dispensing/refinement visit
(completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit)
次要结局
未报告次要终点
研究者
研究点 (3)
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