Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS - Ranges 0-100 mm)
研究概览
简要总结
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
详细描述
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.
Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.
Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
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 (Participant, Investigator)
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
- •Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye
排除标准
- •Monophtalmia
- •Eyelid dysfunction
- •Facial paralysis.
- •Severe dry eye syndrome.
- •Ocular metaplasia.
- •Filamentous keratitis
- •Schirmer test < 5 mm.
- •Best far corrected visual acuity < 1/10.
研究组 & 干预措施
Unifluid
Eye drops in Single Dose Unit
干预措施: Povidone (Drug)
Azithromycin
Eye drops Single dose unit
干预措施: Azithromycin (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS - Ranges 0-100 mm)
时间窗: Baseline and D63 (D63 minus baseline)
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
次要结局
未报告次要终点