Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

NCT01600625 | Completed

• 1 other identifier: 4-2011-0830
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Keywords

meibomian gland dysfunction; inflammatory tear cytokine; minocycline

Outcome Measures

Primary Outcomes (1)

• 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).

  before treatment and after 2 months of treatment

Study Arms (1)

Minocycline treatment group

EXPERIMENTAL

Drug: oral minocycline hydrochloride treatment

Interventions

oral minocycline hydrochloride treatment DRUG

Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment

Minocycline treatment group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (5)

• 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.

  PMID: 2234831 RESULT

• 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.

  PMID: 21450917 RESULT

• 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.

  PMID: 21450915 RESULT

• 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.

  PMID: 21450918 RESULT

• 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.

  PMID: 22967863 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction; cyclopia sequence

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: May 17, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

KR (1)