Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,179
- 主要终点
- Clinical Cure at the Day 4 (EOT)/Exit Visit
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
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
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with bacterial conjunctivitis in 1 or both eyes;
- •Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
- •Agrees to comply with the visit schedule and other requirements of the study;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
- •Presence of concomitant viral infection;
- •Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
- •Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
- •Infants undergoing treatment for retinopathy of prematurity;
- •Contact lens wear during the course of the study;
- •Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
- •Use of medications, as specified in the protocol;
- •Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
- •Known or suspected allergy or hypersensitivity to fluoroquinolones;
- •Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Moxifloxacin AF
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
干预措施: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% (Drug)
Vehicle
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
干预措施: Moxifloxacin AF Vehicle (Other)
结局指标
主要结局
Clinical Cure at the Day 4 (EOT)/Exit Visit
时间窗: Day 4
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
次要结局
- Microbiological Success at the Day 4 (EOT)/Exit Visit(Day 4)