Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

NCT ID: NCT01600625

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minocycline treatment group

Group Type: EXPERIMENTAL

oral minocycline hydrochloride treatment

Intervention Type: DRUG

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

Interventions

oral minocycline hydrochloride treatment

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 2234831 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21450917 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21450915 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21450918 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22967863 (View on PubMed)

Other Identifiers

4-2011-0830

Identifier Type: -

Identifier Source: org_study_id