Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate

Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. To our knowledge, there has been no study on tear cytokine levels in MGD patients treated with topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine the concentration of inflammatory tear cytokines in patients with MGD and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.

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Key information

Conditions

Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of Ophthalmology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion criteria

history of previous ocular or intraocular surgery
ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
history of intolerance or hypersensitivity to any component of the study medications,
wearing contact lenses during the study period, presence of current punctal occlusion,
pregnancy, lactating women, and children.
Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears

Treatment and study plan

topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage

Drug

warm compress only group

Other

Primary outcomes

Changes of inflammatory cytokines in the tears of moderate and severe MGD

Time frame: 1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate

Cytokines were measured using the BD Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzedwere IL-6, IL-7, IL-8, IL-1β, IL-17α, MCP-1, TNF-α, IL-12p70, and IFN-γ. Briefly, 20 μL tear fluid was thawed and added to a 50 μL mixture containing each capture antibody-bead reagent and 50 μL detector antibody-phycoerithrin (Ab-PE) reagent. The mixture was subsequently incubated for 3 h at room temperature, and washed to remove unbound detector Ab-PE reagent before flow cytometry. Data were acquired and analyzed using BD CBA software that calculates the cytokine concentration based on the standard curves and a four-parameter logistic curve-fitting model. Flow cytometry was performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 25, 2012
Registry last updated: Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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