Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Clinical cure [lack of need of additional therapy]
研究概览
简要总结
The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
详细描述
Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).
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
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 3 years to 80 years old.
- •Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- •Intact tympanic membrane
- •Unilateral disease
排除标准
- •Known allergy or sensitivity to Ciprofloxacin or other quinolones.
- •Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
- •Patient has the non intact tympanic membrane.
- •Patient has a serious underlying disease.
- •Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
- •Patients with history of Diabetes mellitus.
- •Patients with more than 80% of the ear canal occluded.
- •Pregnant or lactating patients.
- •Overt fungal Acute Otitis Externa.
- •Local ear canal abnormalities such as abscess, granulation or polyps.
- •Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
- •Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
- •Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
- •Current Infection requiring systemic antimicrobial therapy.
- •Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
研究组 & 干预措施
Ciprodex Otic Suspension
Ciprodex Sterile Otic Solution (Alcon, Inc.)
干预措施: Ciprodex Otic Suspension (Drug)
Ciprodexa Otic Foam
Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)
干预措施: Ciprodexa Otic Foam (Drug)
结局指标
主要结局
Clinical cure [lack of need of additional therapy]
时间窗: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days
Clinical cure \[lack of need of additional therapy\] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea
次要结局
- Otalgia/ear pain(At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14])
- Inflammation/ear edema(At the test-of-cure visit [Day 8 to Day 14])
- Ear discharge/otorrhea(At the test-of-cure visit [Day 8 to Day 14])
- tenderness with movement of pinna(At the test-of-cure visit [Day 8 - Day 14])