Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 768
- 主要终点
- Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
研究概览
简要总结
The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
详细描述
Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months of age.
- •Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
- •Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
- •Agree to refrain from water immersion of the ears during the conduct of the entire study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
- •Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
- •Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
- •Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
- •Prior otologic surgery within 6 months of study entry in the affected ear(s).
- •Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
- •Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-60371
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
干预措施: AL-60371, 0.3% Otic Suspension (Drug)
Vehicle
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
干预措施: AL-60371 Vehicle (Other)
结局指标
主要结局
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
时间窗: Day 11
An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
次要结局
- Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary(Time to event, up to Day 11)
- Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit(Day 11)