Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 主要终点
- Percentage of Subjects With Sustained Clinical Cure at Day 8
研究概览
简要总结
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
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
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
- •Suspected bacterial infection at time of surgery in at least 1 ear.
- •Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
- •Legally Authorized Representative (LAR) must read and sign the informed consent.
- •Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
- •Middle ear pathology in either ear other than otitis media.
- •Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
- •Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
- •Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
EXE844 for 7 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
干预措施: EXE844 Sterile Otic Suspension, 0.3% (Drug)
EXE844 for 7 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
干预措施: Tympanostomy Tube Insertion (Procedure)
EXE844 for 3 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
干预措施: EXE844 Sterile Otic Suspension, 0.3% (Drug)
EXE844 for 3 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
干预措施: Tympanostomy Tube Insertion (Procedure)
Tubes Only
Bilateral myringotomy and tympanostomy tube insertion
干预措施: Tympanostomy Tube Insertion (Procedure)
结局指标
主要结局
Percentage of Subjects With Sustained Clinical Cure at Day 8
时间窗: Day 8
Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
次要结局
- Time to Cessation of Otorrhea(Up to Day 14)
- Percentage of Subjects With Microbiological Success at Day 14(Day 14)