Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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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.

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: oral minocycline hydrochloride treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 children

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline treatment group<br> | Drug: oral minocycline hydrochloride treatment<br>* Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of inflammatory tear cytokine levels | 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). | before treatment and after 2 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meibomian gland dysfunction, inflammatory tear cytokine, minocycline