Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meibomian Gland Dysfunction
Intervention: oral minocycline hydrochloride treatment (Drug)
Phase: N/A
Status: Completed
Sponsored by: Yonsei University
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.
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change of inflammatory tear cytokine levels
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Severance Hospital, Seoul 120-752, Korea, Republic of
Additional Information
Starting date: November 2011
Last updated: March 4, 2014
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