NCT03048526已完成不适用
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tear film thickness as measured with high resolution optical coherence tomography
研究概览
简要总结
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
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
- Single (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
- •Men and women aged over 18 years
- •History of dry eye disease for at least 3 months before the screening visit
- •Be able and willing to follow instructions, including participation in all study assessments and visits
- •Signed and dated written informed consent
排除标准
- •Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters
- •Participation in a clinical trial in the 4 weeks preceding the before the screening visit
- •Active ocular allergies or ocular allergies that are expected to be active during the study period
- •Pregnancy, planned pregnancy or lactating
- •Known hypersensitivity to any component of the study medication
- •Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
研究组 & 干预措施
Hydrabak®
Active Comparator
Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
干预措施: Hydrabak® (Device)
NovaTears®
Experimental
干预措施: NovaTears® (Device)
结局指标
主要结局
Tear film thickness as measured with high resolution optical coherence tomography
时间窗: 4 weeks
次要结局
- Tear film break up time(4 weeks)
- Schirmer I test(4 weeks)
- Lipid layer thickness(4 weeks)
- Non-invasive tear break up time(4 weeks)
- Dynamic Meibomian Gland Imaging(4 weeks)
- Blink frequency(4 weeks)
- Symptom VAS(4 weeks)
- Corneal fluorescein staining(4 weeks)
- Conjunctival lissamine green staining(4 weeks)
- Ocular surface disease index(4 weeks)
研究者
研究点 (1)
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