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Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oral minocycline hydrochloride treatment
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring meibomian gland dysfunction, inflammatory tear cytokine, minocycline

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minocycline treatment group

Arm Description

Outcomes

Primary Outcome Measures

change of inflammatory tear cytokine levels
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).

Secondary Outcome Measures

Full Information

First Posted
May 13, 2012
Last Updated
March 4, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01600625
Brief Title
Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
meibomian gland dysfunction, inflammatory tear cytokine, minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oral minocycline hydrochloride treatment
Intervention Description
Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment
Primary Outcome Measure Information:
Title
change of inflammatory tear cytokine levels
Description
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).
Time Frame
before treatment and after 2 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
2234831
Citation
Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. doi: 10.1097/00006324-199009000-00010.
Results Reference
result
PubMed Identifier
21450917
Citation
Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.
Results Reference
result
PubMed Identifier
21450915
Citation
Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.
Results Reference
result
PubMed Identifier
21450918
Citation
Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
Results Reference
result
PubMed Identifier
22967863
Citation
Lee H, Min K, Kim EK, Kim TI. Minocycline controls clinical outcomes and inflammatory cytokines in moderate and severe meibomian gland dysfunction. Am J Ophthalmol. 2012 Dec;154(6):949-957.e1. doi: 10.1016/j.ajo.2012.06.009. Epub 2012 Sep 8.
Results Reference
derived

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Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

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