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临床试验/NCT01600625
NCT01600625已完成不适用

Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Yonsei University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
change of inflammatory tear cytokine levels

研究概览

简要总结

One of the important factors in obtaining successful outcomes when treating severe meibomian gland dysfunction (MGD) is to control the existing ocular and eyelid inflammation. Thus, in previous studies, topical and systemic antibiotics with anti-inflammatory function, such as topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to treat severe MGD. In this study, minocycline which had the fewest side effects was used to evaluate the effect on cytokine levels in severe MGD. At study initiation, all patients completed an Ocular Surface Disease Index (OSDI) questionnaire and had an ocular surface, tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time (TBUT), Schirmer test, corneal and conjunctival fluorescein staining, microscopic examination of lid margins and meibomian glands, and tear cytokine levels. All measurements except tear cytokine levels were conducted in the same manner before treatment, after 1 month, and after 2 months of treatment. Tear cytokine levels were evaluated before treatment and after 2 months of treatment. The aim of this research was to determine the concentration of inflammatory cytokines in the tears of patients with MGD and to compare the cytokine levels, corresponding clinical responses, and ocular symptoms before and after 2 months of treatment with oral minocycline.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with stage 3 or 4 meibomian gland dysfunction
  • moderate or marked symptoms of ocular discomfort, itching, or photophobia with limitations of activities
  • moderate or severe meibomian gland dysfunction clinical signs
  • mild to moderate conjunctival and peripheral corneal staining or increased conjunctival and corneal staining, including central staining
  • increased signs of inflammation : moderate or severe conjunctival hyperemia, phlyctenulae

排除标准

  • history of previous ocular or intraocular surgery
  • evidence of acute or chronic infections or inflammation of the cornea and conjunctiva
  • ocular allergy
  • autoimmune disease
  • history of intolerance or hypersensitivity to any component of the study medications
  • use of topical ocular medications
  • wearing contact lenses during the study period
  • presence of current punctal occlusion
  • pregnancy
  • lactating women

研究组 & 干预措施

Minocycline treatment group

Experimental

干预措施: oral minocycline hydrochloride treatment (Drug)

结局指标

主要结局

change of inflammatory tear cytokine levels

时间窗: before treatment and after 2 months of treatment

Thirty microliters of phosphate-buffered saline will be injected into the inferior conjunctival sac using a micropipette. Approximately 20 μL tear fluid and buffer will be collected with a micropipette. Cytokines are measured using the BDTM Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzed were interleukin (IL)-1β, IL-6, IL-7, IL-8, IL-12p70, IL-17α, interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α), and monocyte chemotactic protein-1 (MCP-1). Flow cytometry will be performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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