Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Changes of inflammatory cytokines in the tears of moderate and severe MGD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) stage 3 or 4 meibomian gland dysfunction
排除标准
- •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
研究组 & 干预措施
Lotemax with warm compress group
topical loteprednol etabonate (lotemax 0.5%) qid and warm compress & ocular massage (a minimum of four times, once or twice a daily) for 2months
干预措施: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage (Drug)
warm compress only group
warm compress only group
干预措施: warm compress only group (Other)
结局指标
主要结局
Changes of inflammatory cytokines in the tears of moderate and severe MGD
时间窗: 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).
次要结局
未报告次要终点