NCT04521465已完成不适用
A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling
研究概览
简要总结
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.
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
- •Signed ICF (Informed Consent Form) and data protection form
- •Patient-reported history of DED in both eyes
- •Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
- •Have Meibomian Gland Dysfunction (MGD) at Visit
- •Ability and willingness to follow instructions, including participation in all study assessments and visits
排除标准
- •Women who are pregnant, nursing or planning a pregnancy
- •Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
- •Wear of contact lenses
- •Known allergy or sensitivity to the medical device or its components
- •Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit
- •Clinical site employees or immediate family members of the same
结局指标
主要结局
The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling
时间窗: 2 months
This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%).
次要结局
未报告次要终点
研究者
研究点 (1)
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