NCT02356341已完成不适用
NovaTears® Observational Study NT-002
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
- 72
- 试验地点
- 8
- 主要终点
- Subjective symptom severity
研究概览
简要总结
This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •According to NovaTears® instruction for use
- •≥ 18 years
- •Patients with dry eye disease due to meibomian gland dysfunction applying eye lid hygiene for at least 14 days
- •Ability and willingness to provide written Informed Consent
- •Ability and willingness to participate in all examinations
- •Willingness and ability to return for follow up visit
排除标准
- •Patients with hypersensitivity to any of the components of NovaTears®
- •Patients with contact lenses, pregnancies, or who are breast feeding
- •Patients with dry eye disease not caused by meibomian gland dysfunction
- •Patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease
结局指标
主要结局
Subjective symptom severity
时间窗: 6 to 8 weeks
Change in subjective symptom severity score compared to Baseline
次要结局
- Tear-Film Break-up Time(6 to 8 weeks)
研究者
研究点 (8)
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