NCT01357538已完成4 期
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
研究概览
简要总结
This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.
详细描述
Reduction of signs and symptoms of blepharitis
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
- Quadruple (Participant, Care Provider, 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
- •written informed consent
- •ambulatory male and female patients 18 years of age or older
- •summarised score of signs and symptoms of blepharitis of 15 or more at baseline
排除标准
- •different ocular conditions
- •different system conditions
- •several concomitant medications
研究组 & 干预措施
Posiformin 2 %
Active Comparator
Eye ointment applied to the eye lid
干预措施: Posiformin 2 %, bibrocathol (Drug)
Placebo
Placebo Comparator
corresponding vehicle, eye ointment applied to the eye lid
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
时间窗: 14 days
Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination
次要结局
- Changes in blepharitis signs and symptoms(14 days)
研究者
研究点 (1)
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