Efficacy and Safety of Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Total subjective symptoms score (TSSS)
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of topical Tacrolimus eye drops in different concentrations in treatment of vernal keratoconjunctivitis (VKC) comparing it with Steroid based usual topical regimen
详细描述
A hospital- based Prospective comparative randomized open label controlled trial . the study will be conducted on Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group). they will be divided into 2 groups control group will be treated with usual regimen ( steroid based) interventional group will be subdivided into 2 groups and each will be treated with Tacrolimus eye drops in 2 different concentrations
Follow up visits:
Will be scheduled 1st week , 2nd week then 4th week during the loading period Then every 2 weeks during the maintenance period Then monthly for another 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)
排除标准
- •Coexisting eye infections
- •Contact lens use
- •Systemic immunosuppressive drug use
- •Herpes keratitis
- •Recent ocular surgery or trauma
- •Known hypersensitivity to Tacrolimus
- •Ophthalmological comorbidities as cataract, glaucoma, and congenital eye anomalies
- •Impaired renal or hepatic functions
研究组 & 干预措施
Control group
This group will be treated by steroid eye drops
干预措施: Steroid eye drops (Drug)
Intervention group 1
This group will be treated by compound Tacrolimus eye drop in 0.1% concentration
干预措施: Tacrolimus eye drops (Drug)
Intervention group 2
This group will be treated by compound Tacrolimus eye drop in 0.01% concentration
干预措施: Tacrolimus eye drops (Drug)
结局指标
主要结局
Total subjective symptoms score (TSSS)
时间窗: during loading period of drug intake ( 1 month )
management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total subjective symptoms score (TSSS)
Total objective ocular signs score (TOSS)
时间窗: during loading period of drug intake ( 1 month )
management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total objective ocular signs score (TOSS)
visual acuity
时间窗: during loading period of drug intake ( 1 month )
management of acute episodes : with follow up of visual acuity using snellen chart
IOP measurement
时间窗: during loading period of drug intake ( 1 month )
management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
次要结局
- time of persistence(during maintenance period of drug intake ( 2 months))
研究者
Esraa Ahmed Okasha
principle investigator
Sohag University