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临床试验/ChiCTR-IPC-14005386
ChiCTR-IPC-14005386进行中(未招募)4 期

肝素滴眼液對於春季角膜結膜炎的療效的實驗研究:隨機對照試驗

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年11月7日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
48
试验地点
1
主要终点
Efficacy of heparin eye drops on the objective signs, and ocular symptoms form the Visual Analog Scale

研究概览

简要总结

肝素滴眼液對於春季角膜結膜炎的療效

研究设计

研究类型
干预性研究
主要目的
随机平行对照
盲法
Double

入排标准

年龄范围
5 至 100(—)
性别
All

入选标准

  • Age 5 years or older;
  • Diagnosed with bilateral vernal keratoconjunctivitis based on the history and clinical examination;
  • Grade 1 (mild, intermittent), grade 2A (moderate, intermittent), grade 2B (moderate, persistent), and grade 3 (severe) VKC.

排除标准

  • Age less than 5 years;
  • Grade 4 (very severe), and grade 5 (evolution) VKC;
  • Any other active ophthalmic disease;
  • Pregnancy or breastfeeding;
  • Solid organ transplant recipients;
  • Blood disorders;
  • Hypersensitivity to heparin or related products.

研究组 & 干预措施

Two groups

HyloPARIN eye drops 4 times a day versus Heparin eye drops (Placebo) for 6 weeks

结局指标

主要结局

Efficacy of heparin eye drops on the objective signs, and ocular symptoms form the Visual Analog Scale

次要结局

  • Changes in the tear cytokine profile before and after the treatment
  • Visual acuity outcomes;
  • Requirement of additional treatment in the form of topical mast cell stabilizers or corticosteroids;
  • Complications associated with the treatment and disease per se.

研究者

发起方
Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong

研究点 (1)

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