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Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

This study is currently recruiting participants.
Verified May 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01600625
First received: May 13, 2012
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Meibomian Gland Dysfunction
 Drug: oral minocycline hydrochloride treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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).



Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline treatment group Drug: oral minocycline hydrochloride treatment
Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600625

Contacts
Contact: Tae-im Kim, MD 82-2-2228-3574 tikim@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Tae Im Kim, MD     82-2-2228-3574     tikim@yuhs.ac    
Principal Investigator: Tae Im Kim, MD            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01600625     History of Changes
Other Study ID Numbers: 4-2011-0830
Study First Received: May 13, 2012
Last Updated: May 16, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
meibomian gland dysfunction
inflammatory tear cytokine
minocycline

Additional relevant MeSH terms:
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013