Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in tear film thickness
研究概览
简要总结
Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES), affecting millions of people worldwide. We have shown in a previous study that tear film thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems that topical azithromycin is more effective than tetracyclines and also has the advantage of better tolerability. The hypothesis of the present study is that topical treatment with azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in patients with DES caused by MGD.
The objective of this study is to compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with DES caused by MGD.
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
- •Signs of meibomian gland plugging or expressibility of the meibomian glands.
- •DES most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DES, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator
- •Signed and dated written informed consent.
- •History of dry eye syndrome for at least 3 months
- •Normal ophthalmic findings except dry eye syndrome and MGD, ametropia < 6 Dpts
- •BUT ≤ 10 seconds
排除标准
- •Participation in a clinical trial in the 3 weeks before the screening visit
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
- •Treatment with corticosteroids in the 4 weeks preceding the study
- •Wearing of contact lenses
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants Ocular infection
- •Ocular surgery in the 6 months preceding the study
- •Pregnancy, planned pregnancy or lactating
- •Contraindication against the use of topical azithromycin or oral doxycycline
研究组 & 干预措施
Azithromycin
Preservative-free azithromycin 15mg/g (Azyter® Augentropfen im Einzeldosisbehältnis, Thea, Clermont-Ferrand, France) one drop twice daily for two days then once daily for 26 days
干预措施: Azithromycin (Drug)
Doxycycline
Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks
干预措施: Doxycycline (Drug)
结局指标
主要结局
Change in tear film thickness
时间窗: 8 weeks
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
次要结局
- Change in conjuctival staining with lissamine green(8 weeks)
- Change in break up time (BUT)(8 weeks)
- Change in Visual Acuity(8 weeks)
- Change in impression cytology(8 weeks)
- Change in meibography(8 weeks)
- Change in corneal sensitivity(8 weeks)
- Change in lipid layer thickness(8 weeks)
- Change in tear osmolarity(8 weeks)
- Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)(8 weeks)
- Change in intraocular pressure(8 weeks)
- Change in Schirmer I test(8 weeks)
- Change in signs and symptoms of meibomian gland disease (MGD)(8 weeks)
- Change in Staining of the cornea with fluorescein(8 weeks)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr
Medical University of Vienna