NCT04125394Unknown不适用
Unicentric Clinical Trial on the Clinical Efficacy and Tolerance of the Treatment With an Ophthalmic Solution of Hypertonic Sodium Chloride (NaCl 5%) Without Preservatives in Patients Suffering From Symptomatic Corneal Edema
Tiedra Farmacéutica SL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in Visual acuity
研究概览
简要总结
Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved.
- •No need for keratoplasty in the 6 months following the start of the study
排除标准
- •Visual acuity less than 1/20 in both eyes
- •Corneal edema caused by the following acute etiologies: trauma, infection, inflammation or Stevens-Johnson syndrome.
- •Glaucoma or uncontrolled hypertension.
- •Known allergy to any of the ingredients of the product.
结局指标
主要结局
Mean Change from Baseline in Visual acuity
时间窗: Baseline, Day 7 and Day 28
次要结局
- Mean Change from Baseline in Corneal Thickness(Baseline, Day 7 and Day 28)
研究者
研究点 (1)
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