Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- duration of ttt
研究概览
简要总结
Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.
Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with herpetic stromal keratitis
排除标准
- •associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
研究组 & 干预措施
group A
receive cyclosporine eye drops together with prednisolone eye drops.
干预措施: cyclosporine A 0.05% eye drops (Drug)
group B
receive topical prednisolone with placebo eye drops (tear replacement).
干预措施: cyclosporine A 0.05% eye drops (Drug)
结局指标
主要结局
duration of ttt
时间窗: 3 months
duration of treatment until complete resolving of keratitis
次要结局
- improvement in visual acuity(3 months)
研究者
Nancy Lotfy, MD
Dr
Farwaniya Hospital