Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction - 9 Months Follow-up Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- OSDI score
研究概览
简要总结
The goal of this observational study (spontaneous, non-randomised, prospective cohort, phase IV) is to compare the efficacy and safety of two different oral doxycycline treatment protocols (LCP - Low dose continuous protocol & FPP - Full dose pulsed protocol) for meibomian gland dysfunction (MGD) in patients with refractory MGD (OSDI > 13 after at least 2 months treatment with warm compresses and lacrimal substitutes - first-line therapy). Systemic doxycycline doesn't have a standardized treatment protocol and this is why those patients are treated as in normal clinical practice. The main questions it aims to answer are:
Which treatment protocol has a greater impact on patient symptoms during the follow-up (OSDI score reduction)? Which treatment protocol has a greater impact on patient signs during the follow-up (TBUT and corneal staining variations)? Which treatment protocol is safer (in terms of adverse events rate)?
Participants will be visited every 3 months (V0-V1-V2-V3) with signs and symptoms assessment (TBUT, corneal staining, OSDI score) after being treated for 3 months with the assigned doxycycline treatment protocol (LCP or FPP).
详细描述
This spontaneous, prospective, non-randomized, parallel-group, phase IV study was conducted in compliance with the tenets of the Declaration of Helsinki.
All study participants were fully consented, and written informed consent was obtained.
This study included patients with refractory MGD. Refractory MGD is defined as symptomatic MGC (OSDI > 13 points) despite 2 months of first-line treatment with lacrimal substitutes 3 times per day and meibomian gland expression with warm compresses twice per day.
The study will consist of 3 visits: Baseline (day 0), Visit 2 (day 90 ± 5 - 3rd month), Visit 3 (day 180 ± 5 - 6 month). At each visit, patients will receive an OSDI questionnaire, NIBUT, type I Schirmer test and AS assessment, including TBUT, corneal staining (Oxford scale) At baseline, eligible patients will be enrolled and treated with the assigned protocol. The investigators will assign the protocol (non-randomized) in a 1:1 ratio.
At Visit 2, NIBUT, TBUT, Oxford scale and OSDI improvement will be evaluated compared with Visit 1. Patients will be carefully asked about their compliance with the treatment. Patients who interrupted the treatment for adverse events or low compliance (<75% of the protocol adherence) will exit the study and be excluded from the analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LCP - Low dose continuous protocol
Assumption of 50 mg of oral doxycycline per day for 3 months
干预措施: Doxycyclin (Drug)
FPP - Full dose pulsed protocol
Assumption of 100 mg of oral doxycycline per day for 15 days per month (with a subsequent 15 days of washout) for 3 months
干预措施: Doxycyclin (Drug)
结局指标
主要结局
OSDI score
时间窗: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Ocular Surface Disease Index
次要结局
- Adverse events(From baseline up to the 3rd month)
- TBUT(Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days))
- Corneal staining(Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days))
研究者
Paolo Fogagnolo
Associate professor
University of Milan