A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Otoscopic Examination: Tympanic Membrane
研究概览
简要总结
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
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
- None
入排标准
- 年龄范围
- 6 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.1 mL OTO-201
Ciprofloxacin
干预措施: OTO-201 (ciprofloxacin) (Drug)
0.2 mL OTO-201
Ciprofloxacin
干预措施: OTO-201 (ciprofloxacin) (Drug)
0.4 mL OTO-201
Ciprofloxacin
干预措施: OTO-201 (ciprofloxacin) (Drug)
结局指标
主要结局
Otoscopic Examination: Tympanic Membrane
时间窗: Up to 1 month
Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)
Otoscopic Examination: Middle Ear
时间窗: Up to 1 month
Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)
Feasibility of Administration
时间窗: Day1
Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".
Overall Adverse Events
时间窗: up to 1 month
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
次要结局
- Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)(Day 15 (two weeks from dosing))
- Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)(Day 15 (2 weeks from dosing))