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
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
- 2
- 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
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 (2)
Loading locations...
相似试验
尚未招募
Unknown
Influence of perfluorohexyloctane on tear film and higher order aberrationsH52.7Disorder of refraction, unspecifiedDRKS00030660Klinik für Augenheilkunde Universität Düsseldorf250
Unknown
不适用
Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye SyndromeDry EyeNCT02992392Sun Yat-sen University50
已完成
4 期
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease PatientsDry Eye SyndromesDry EyeNCT04127851Taejoon Pharmaceutical Co., Ltd.438
招募中
2 期
Comparison of clinical outcome in dry eye treatment between corneal epithelial thickness assessment with spectral domain optical coherence tomography and clinical assessmentCorneal epithelial thickness measured by spectral domain optical coherence tomography can use for grading dry eye severity and have effect on treatment efficacyCorneal epithelial thickness, spectral domain optical coherence tomography, dry eye diseaseTCTR20210706006/A92
已完成
不适用
Effects of Two Tear Substitutes in Patients With Dry Eye SyndromeTear FilmLipid LayerLiposicTears Naturale ForteDry EyeNCT03211351Huaxia Eye Hospital Group95