A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- the change of objective ocular signs
研究概览
简要总结
To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC patients who were not responding to conventional treatments. All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. After the first month, LE/T will be stopped, with other treatments continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The primary endpoints are the change in symptoms and objective signs. Treatment failure will be recorded if extra corticosteroids were required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vernal keratoconjunctivitis patients resistant to conventional treatments
排除标准
- •Patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus
研究组 & 干预措施
tacrolimus and loteprednol etabonate/tobramycin
topical eye drops
干预措施: Tacrolimus (Drug)
结局指标
主要结局
the change of objective ocular signs
时间窗: before treatment and 1, 2, 3 and 6 months after treatment
doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
次要结局
- the change of Best corrected visual acuity(before treatment and 1, 2, 3 and 6 months after treatment)
- the change of intraocular pressure(before treatment and 1, 2, 3 and 6 months after treatment)
- the change of subjective ocular symptoms(before treatment and 1, 2, 3 and 6 months after treatment)
研究者
Jin Yuan
professor
Zhongshan Ophthalmic Center, Sun Yat-sen University