Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01600625
Collaborator
(none)
46
1
1
16
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral minocycline hydrochloride treatment
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital Seoul Korea, Republic of 120-752

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01600625
Other Study ID Numbers:
  • 4-2011-0830
First Posted:
May 17, 2012
Last Update Posted:
Mar 5, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Yonsei University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2014