Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Not Applicable

Completed

• Conditions: Meibomian Gland Dysfunction
• Interventions: Drug: oral minocycline hydrochloride treatment

• Registration Number: NCT01600625
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-05-13
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Primary Completion: 2012-07
• Study Completion: 2013-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minocycline treatment group	oral minocycline hydrochloride treatment	-

Primary Outcome Measures

Name	Time	Method
change of inflammatory tear cytokine levels	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).

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of