AONDA Therapeutic Indication Study I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Change from baseline in corneal pain at the Follow-up Visit
研究概览
简要总结
This study will be used to support assessment of AIR OPTIX® NIGHT & DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.
详细描述
In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline.
- •Baseline and Follow-up (up to 1 year from Baseline) charts available.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
- •Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in corneal pain at the Follow-up Visit
时间窗: Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits.
次要结局
未报告次要终点