Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

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.

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Key information

Conditions

Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases cyclopia sequence

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral minocycline hydrochloride treatment

Drug

Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment

Primary outcomes

change of inflammatory tear cytokine levels

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: May 17, 2012
Registry last updated: Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed