跳至主要内容
临床试验/CTRI/2025/08/092978
CTRI/2025/08/092978尚未招募不适用

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.

Sankara eye hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月25日最近更新:

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

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Pallavi Joshi

Sankara eye hospital

研究点 (1)

Loading locations...

相似试验