Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01600625
First received: May 13, 2012
Last updated: March 4, 2014
Last verified: March 2014

May 13, 2012
March 4, 2014
November 2011
July 2012   (final data collection date for primary outcome measure)
change of inflammatory tear cytokine levels [ Time Frame: before treatment and after 2 months of treatment ] [ Designated as safety issue: No ]

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).

Same as current
Complete list of historical versions of study NCT01600625 on ClinicalTrials.gov Archive Site
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Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction
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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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Meibomian Gland Dysfunction
Drug: oral minocycline hydrochloride treatment
Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment
Experimental: Minocycline treatment group
Intervention: Drug: oral minocycline hydrochloride treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01600625
4-2011-0830
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP