Efficacy and Safety of Oral Doxycycline in Chronic Meibomian Gland Dysfunction: A Randomized Control Trial (The ODCMD trial)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- To compare the efficacy of high versus low dose of Doxycycline on Tear Film Breakup Time (TBUT).
研究概览
简要总结
Doxycycline is already being used clinically and is in place in the management of chronic meibomian gland dysfunction associated dry eye disease including the below mentioned guidelines.
Indian Guideline: If chronic symptoms and signs of MGD are not adequately controlled by eyelid cleansing or meibomian gland expression, daily oral doxycycline, minocycline, or tetracycline may be helpful and tapered when clinical improvement is documented. [Guideline name: Evaporative dry eye disease due to meibomian gland dysfunction: Preferred practice pattern guidelines for diagnosis and treatment. Indian J Ophthalmol 2023;71:1348-56].
International workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction:
Systemic tetracycline derivatives (e.g., tetracycline 250 mg four times per day or doxycycline 100 mg two times per day) for 6 weeks to several months in recurrent cases,
Recommendations in Clinical Handbooks for Treatment of Posterior Blepharitis and Meibomitis:
Moorfields Manual: With corneal involvement: Doxycycline 100 mg once a day or Erythromycin 250 mg four times a day for 8 weeks.
Wills Eye Manual: Tetracycline 250 mg four times a day or doxycycline 100 mg twice a day for 6 weeks.
Japan: Oral administration of azithromycin and tetracycline antimicrobials (doxycycline and minocycline) is effective in improving subjective symptoms and meibomian gland orifice/surrounding findings in patients with MGD.
This is to be noted that patients are already getting Doxycycline 100 mg BD (the high dose mentioned in our study) as per different guideline recommendations. However, single low sample RCT has showed that efficacy is similar in both the cases (high dose and low dose of doxycycline), however adverse effects were quite lower with the lower dose compared to the traditionally used higher dose.
Given the potential side effects associated with traditional higher doses of Doxycycline (100 mg BD), such as gastrointestinal disturbances, this current study aims to fill the gap by directly comparing low and high doses of Doxycycline, to evaluate their relative efficacies and safety profiles in managing chronic MGD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18–60 years.
- •Diagnosis of chronic MGD Based on clinical signs (meibomian gland expressibility, meibum quality, glandular atrophy) and symptoms (dry eye, grittiness, and irritation).
- •3.Symptom severity Moderate to severe MGD, as determined by the Ocular Surface Disease Index (OSDI) score and the Meibomian Gland Dysfunction Scale.
- •5.Informed consent Signed informed consent form, acknowledging the voluntary nature of participation and the potential risks involved.
排除标准
- •1.Presence of other ocular conditions: Active ocular infection, ocular surface disease (e.g., severe blepharitis, keratoconus), or any other significant eye disease that could confound study outcomes.
- •2.Severe systemic disease: Uncontrolled systemic conditions such as cardiovascular disease, liver disease, or autoimmune disorders that may interfere with the safe use of doxycycline.
- •3.Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding during the study period.
- •4.Use of contraindicated medications: Current use of medications that interact with Doxycycline, such as anticoagulants, or use of other oral antibiotics for MGD in the past 30 days.
- •5.Allergy to Doxycycline: Known hypersensitivity or allergy to Doxycycline or other tetracycline-class antibiotics.
- •6.Recent ocular surgery or procedures: Any ocular surgery (e.g., cataract surgery) or eye procedure (e.g., punctal plugs) within the last 3 months.
- •7.Current use of topical steroids: Use of ocular steroids or other anti-inflammatory medications within 4 weeks prior to enrollments.
结局指标
主要结局
To compare the efficacy of high versus low dose of Doxycycline on Tear Film Breakup Time (TBUT).
时间窗: Baseline | 8 weeks | 5 months | 8 months
次要结局
- 1. To compare the safety of high versus low dose of Doxycycline among patients with Chronic Meibomian Gland Dysfunction.(2. To compare the efficacy of high versus low dose of Doxycycline on meibomian gland dysfunction score (MGD score).)
研究者
Dr Phulen Sarma
AIIMS, Guwahati