NCT03460548终止不适用
A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- OSSF
研究概览
简要总结
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.
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
- Double (Investigator, Outcomes Assessor)
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
- •With at least a 3-month documented history of bilateral dry eye
- •With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
- •With at least one objective sign of tear deficiency
- •With Ocular Surface Disease Index (OSDI) score of ≥ 18
排除标准
- •Refractive surgery within 12 months prior to selection
- •Any other ocular surgery or ocular trauma within 6 months prior to selection
- •Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs
结局指标
主要结局
OSSF
时间窗: Day 28
Ocular surface staining with fluorescein (OSSF)
次要结局
未报告次要终点
研究者
研究点 (1)
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