Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in tear film thickness
研究概览
简要总结
The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several therapeutic strategies have been proposed, but still no ideal regimen has been found. Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based on optical coherence tomography (OCT) has been developed. It has been shown in previous studies that TFT correlates well with objective signs as well as with subjective symptoms of DES.
In the present study the effects of three different topical lubricants (Neovis total multi®, Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to severe DES will be investigated using this device.
Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during this study day will provide information about the corneal residency time of the three different eye drops. Patients with moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be performed before and at pre-specified time points after instillation as secondary outcome.
Other clinical measures for DES such as determination of tear film break up time (TFBUT), corneal fluorescein staining, Schirmer I test and subjective assessments will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dry Eye Neovis
20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops
干预措施: Neovis Total Multi® Eye Drops (Device)
Dry Eye Vismed
20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops
干预措施: Vismed Multi® Eye Drops (Device)
Dry Eye Hydrabak
20 Patients with dry eye syndrome receiving Hydrabak Eyedrops
干预措施: Hydrabak® Eye Drops (Device)
结局指标
主要结局
Change in tear film thickness
时间窗: 1 day
Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops
次要结局
- Visual acuity(2 weeks)
- Ocular Surface Disease Index (OSDI) score(1 day)
- Intraocular pressure (IOP)(1 day)
- Visual Analogue Scale (VAS)(2 weeks)
- Schirmer I test(2 weeks)
- Corneal fluorescein staining(2 weeks)
- Change in lipid layer thickness(1 day)
- Tear Break Up Time (TBUT)(2 weeks)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna
