NCT00565123已完成2 期
A Single- Centre, Randomised Study Of The Clinical And Microbiological Efficacy Of Decreasing The Dosage Of Levofloxacin 0,5% Eye Drops As Compared To Standard Eye Drop Dosage In Patients With Bacterial Conjunctivitis
Laser Microsurgery Centre, Poland1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint was the clinical cure.
研究概览
简要总结
The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 70 years of age
- •Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
- •Patients who have given and signed informed consent
- •The ability and willingness to comply with all study procedures
排除标准
- •Insulin Dependent Diabetes Mellitus (IDDM)
- •Patients with keratitis or hordeolum
- •Sjogren's Syndrom and "Sick Eye's Syndrom".
- •Ectropion, entropion;
- •Using contact lenses during the study
- •Poor visual acuity in the other eye
- •Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
- •Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
- •Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
- •Concurrent other eye drops
- •All ocular surgeries which were performed less than 6 months before the beginning of the study.
- •Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
- •History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
- •Hypersensitivity to fluoroquinolons and benzalkonium chloride;
- •Intended or ascertained pregnancy or lactation;
- •Participation in a clinical trial within last 30 days.
研究组 & 干预措施
Group A
Experimental
Experimental dosage
干预措施: 0.5% levofloxacin eye drops (Drug)
Group B
Active Comparator
Classical dosage
干预措施: 0.5% levofloxacin eye drops (Drug)
结局指标
主要结局
The primary efficacy endpoint was the clinical cure.
时间窗: 7(+-1) days
次要结局
- The secondary efficacy end point was the microbiological eradication.(7(+-1) days)
研究者
研究点 (1)
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