A comparative study to evaluate clinicopathological changes associated with usage of topical cyclosporine A 0.09 percent versus lifitegrast 5 percent eyedrops in patients with dry eye disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
This randomized controlled trial aims to evaluate and compare the clinico-pathological changes in patients with Dry Eye Disease treated with Cyclosporine A 0.09 percentage and Lifitegrast 5 percentage at Sankara Eye Hospital, Bangalore. Dry eye disease is a multifactorial condition marked by tear film instability and ocular surface inflammation. Eligible patients above 18 years with various forms of dry eye disease will undergo a drug-free period before being randomly assigned to either treatment group. Clinical assessment of dryness using Schirmers test, Keratograph, Tear film breakup time, Corneal staining pattern and Symptom score will be checked at baseline and week 12. Impression cytology of the cornea and conjunctiva will be performed at baseline and week 12 to assess squamous metaplasia, goblet cell density, and cellular morphology. The study seeks to correlate clinical improvements with pathological changes, providing insight into the efficacy of these immunomodulatory therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Mild to moderate dry eye disease Stain score more than 3 and less than 9 Symptom score more than 7 Patients willing to discontinue current therapy.
排除标准
- •Patients on immunomodulator therapy within 3 months Patients with glaucoma, Uveitis, tumors, trauma history Patients with previous corneal surgery.
结局指标
主要结局
Clinical evaluation
时间窗: Baseline and week 12
Keratograph
时间窗: Baseline and week 12
Schirmers
时间窗: Baseline and week 12
TBUT
时间窗: Baseline and week 12
Corneal and Conjunctival staining score
时间窗: Baseline and week 12
Patient response score
时间窗: Baseline and week 12
次要结局
- Pathological evaluation by impression cytology(Conjunctival goblet cell density)
研究者
Dr Pallavi Joshi
Sankara eye hospital
