An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 985
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bacterial conjunctivitis based on clinical observation.
- •Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
- •Willing to complete all required study procedures and visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women who are pregnant, lactating, or planning a pregnancy.
- •Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
- •Planned contact lens wear during the course of the study.
- •Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
- •Suspected fungal, viral, or Acanthamoeba infection.
- •Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
- •History of recent surgery.
- •Presence of concomitant systemic viral infection.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Moxifloxacin
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
干预措施: Moxifloxacin ophthalmic solution, 0.5% (Drug)
Ofloxacin
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
干预措施: Ofloxacin ophthalmic solution, 0.3% (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: Day 9
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
Microbiological Success Rate
时间窗: Day 9
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.
次要结局
未报告次要终点