Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Laboratoires Thea0 个研究点开始时间: 2001年4月1日最近更新: 2006年7月27日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Laboratoires Thea
主要终点: ECP tear concentration

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis

详细描述

The objective of this pilot study is to evaluate the clinical and biological efficacy of preservative free NAAGA eyedrops in VKC -by in particular the levels of ECP and MPO in tears- comparatively to the activity of levocabastine eyedrops.

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: 4 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with vernal keratoconjunctivitis,
•mild or moderate : clinical score >3 and <= 14, calculated from 4 major symptoms (itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs (conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates and corneal epithelial disease)
•age >= 4 years old

排除标准

•no occurrence of ocular trauma or infection (within the 3 months preceding the study),
•no ocular medical treatment (topical or not) within the 5 days preceding the study,
•no ocular laser (within the 3 previous months),
•no ocular surgery (within the previous year),
•patient who signs the informed consent form (or his/her parents or legal guardian in the case of underage patient).

结局指标

主要结局

ECP tear concentration

次要结局

Tolerance

研究者

发起方

Laboratoires Thea

申办方类型

Industry

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