Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
研究概览
简要总结
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
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. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. 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.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and older eligible to sign by themselves.
- •Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- •Intact tympanic membrane
- •Unilateral Acute Otitis Externa
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.
- •Bilateral Acute Otitis Externa.
- •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
Ciloxan Ear Drops
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
干预措施: 0.3% Ciprofloxacin Ear Drops (Drug)
Foam Otic Cipro
Patients randomized to this study arm will receive the experimental product
干预措施: 0.3% Ciprofloxacin Foam Otic Cipro (Drug)
结局指标
主要结局
Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
时间窗: within 7 days after completion of treatment (BID, for 7 days)
次要结局
未报告次要终点