- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01600625
Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Minocycline treatment group
|
Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of inflammatory tear cytokine levels
Time Frame: before treatment and after 2 months of treatment
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0830
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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