Randomized, open-label, pilot clinical trial to evaluate the efficacy of Saindhavadi Anjana in Meibomian Gland Dysfunction (MGD) associated Dry Eye Disease (DED)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in OSDI score from baseline
研究概览
简要总结
Dry eye is a multi-factorial disease of the ocular surface characterized by loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. Conventional treatment modalities of MGD only provide symptomatic relief and treatment like Intense Pulse Light (IPL) can be economic burden for patients. This study will be conducted in patients presenting with signs and symptoms of Shushkakshipaka. Patients presenting with signs of MGD, TBUT <5 seconds and Schirmer’s test <10mm.
Saindhavadi Anjana will be applied once daily in evening followed by prakshalana with clean water and Carboxymethyl cellulose 0.5% eye drops 4 times /day in intervention group. Azithromycin 1% eye ointment once in evening daily and Carboxymethyl cellulose 0.5% eye drops 4 times/day will be applied in control group. All the parameters will be analysed by applying appropriate parametric or non- parametric tests for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed ICF (Informed Consent Form) Patients presenting with signs and symptoms of Shushkakshipaka Patients presenting with signs of MGD Ocular dryness Meibomian gland orifice plugging Lid margin telangiectasia TBUT less than 5 seconds Schirmer’s test less than 10mm.
排除标准
- •Cases complicated with acute, chronic, infective conjunctivitis or any specific eyelid disorder, corneal ulcer, dacryocystitis and lagophthalmos Inflammatory diseases unrelated to MGD Patients suffering from any systemic disorder or taking any medications which in the opinion of PI may affect the clinical outcome of the trial Contact lenses use History of ocular surgery within 6 months prior to enrolment in trial Pregnancy or child bearing age without contraception Stevens-Johnson syndrome Chemical, thermal or radiation injury Sjogren’s syndrome Patient who starts developing complications will be excluded from the study Patient not willing for the treatment Ongoing ocular or systemic infection Ocular or periocular malignancy Use of topical steroids, topical cyclosporine, topical anti-glaucoma medication within 60 days before screening Lid structural abnormality not caused by MGD.
结局指标
主要结局
Change in OSDI score from baseline
时间窗: 30 Days
次要结局
未报告次要终点
研究者
Nilkanthe Anuradha Gulabrao
Institute of Medical Sciences, Banaras Hindu University