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Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01600625
Enrollment
46
Registered
2012-05-17
Start date
2011-11-30
Completion date
2013-03-31
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction

Keywords

meibomian gland dysfunction, inflammatory tear cytokine, minocycline

Brief summary

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.

Interventions

DRUGoral minocycline hydrochloride treatment

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of inflammatory tear cytokine levelsbefore treatment and after 2 months of treatmentThirty 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026