Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness in Subjects With Dry Eye Disease, Meibomian Gland Dysfunction, Blepharospasm and Healthy Subjects - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tear film lipid layer thickness as measured with Lipiview II
研究概览
简要总结
Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse.
The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects.
Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed
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
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Ametropy < 6 dpt
- •No application of eye drops or ointments in the 24 hours preceding the screening visit as well as the study day Dry eye disease group
- •History of dry eye disease ≥ 3 months
- •Schirmer I test ≤ 10 mm and ≥ 2 mm or BUT ≤ 10 sec
- •Normal ophthalmic findings with the exception of DED Meibomian gland disease group
- •Dry eye disease most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DED, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator
- •History of dry eye disease ≥ 3 months
- •Normal ophthalmic findings except dry eye disease
- •BUT ≤ 10 seconds Blepharospasm group
- •Clinical diagnosis of blepharospasm
- •Normal ophthalmic findings with the exception of blepharospasm and dry eye
- •Schirmer I test > 10 mm and BUT > 10 sec
排除标准
- •Clinically relevant illness in the 3 weeks before the screening or study day
- •Ametropy ≥ 6 dpt
- •Pregnancy or planned pregnancy
- •Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
- •Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medical device used in the study
- •Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing or in the last 4 weeks
- •Treatment with medication known to have a detrimental effect on tear film (e.g. antidepressants, anxiolytics, neuroleptics, antihistaminic drugs, cholinergic drugs, antimuscarinic drugs, phenothiazine, beta blockers): treatment duration ≤ 4 weeks or changed dose since ≤ 4 weeks or during the study
- •Alcohol abuse
- •Contact lens wear Meibomian gland dysfunction group
- •Sjögren's syndrome
研究组 & 干预措施
Group 1
10 male and female healthy subjects receive Cationorm MD sine eye drops once
干预措施: Cationorm MD sine eye drops (Drug)
Group 2
10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once
干预措施: Cationorm MD sine eye drops (Drug)
Group 3
10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once
干预措施: Cationorm MD sine eye drops (Drug)
Group 4
10 male and female volunteers with receive Cationorm MD sine eye drops once
干预措施: Cationorm MD sine eye drops (Drug)
结局指标
主要结局
Tear film lipid layer thickness as measured with Lipiview II
时间窗: 12.04.2017-30.12.2018
次要结局
未报告次要终点
研究者
Gerhard Garhofer
Assoc.Prof.PD MD
Medical University of Vienna