A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 45
- 主要终点
- Number of Participants With Clinical Cure of AOE
研究概览
简要总结
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.
详细描述
This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, 6 months of age and over;
- •Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
- •Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
- •AOE of <4 weeks duration;
- •Intact tympanic membrane(s) in the treated ear(s);
- •Willingness to refrain from swimming through the TOC/ Visit 5;
- •For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;
- •Ability to complete the study in compliance with the protocol;
- •For adult subjects, ability to understand and provide written informed consent; and
- •For pediatric subjects, a parent or legal guardian has provided written informed consent; and
- •For children age 6 and above, ability to understand and provide assent according to institutional requirements.
排除标准
- •Acute or chronic suppurative otitis media;
- •Post-tympanostomy tube acute otorrhea;
- •Malignant otitis externa;
- •Suspected or overt fungal or viral ear infection;
- •Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
- •Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;
- •Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
- •Malignant tumors of the external auditory canal of the treated ear(s);
- •History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery >6 months prior to Baseline;
- •Four or more episodes of otitis externa (OE) in the previous year;
- •Uncontrolled diabetes mellitus;
- •Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
- •Renal insufficiency;
- •Hepatitis or hepatic insufficiency;
- •Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
- •Receipt of topical otic antibiotic within 24 hours prior to Baseline;
- •Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
- •Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
- •Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
- •Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
- •Pregnancy, planned pregnancy, or lactation;
- •Known sensitivity or intolerance to quinolone antibacterial agents;
- •Previous participation in this trial;
- •Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
- •Significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
研究组 & 干预措施
Ciprodex®, RLD
Ciprodex®, Otic Suspension, Twice daily for 7 days
干预措施: Ciprodex® (Drug)
EXL CDOS
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days
干预措施: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension (Drug)
结局指标
主要结局
Number of Participants With Clinical Cure of AOE
时间窗: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).
次要结局
- Number of Participants With Microbiological Cure (MC)(7 days after the completion of therapy; at Day 15 (+/- 1 day))