Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600625
• Other study ID #: 4-2011-0830
• Status: Completed
• Phase: N/A
• First received: May 13, 2012
• Last updated: March 4, 2014
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. — View 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. — View 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;5 — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)-1ß, IL-6, IL-7, IL-8, IL-12p70, IL-17a, interferon-? (IFN-?), tumor necrosis factor-a (TNF-a), 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	No