NCT05370209终止不适用
A Prospective, Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Otinova® Ear Spray When Used in the Treatment of External Otitis Symptoms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
研究概览
简要总结
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 5 years old
- •Clinical diagnosis of otitis externa based on otoscopic exam:
- •a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the OE signs (swelling, erythema and otorrhea)
- •Ability to correctly administer Otinova as spray (not requiring tamponade), as judged by the Investigator
- •Subject agrees to refrain from water immersion of the ears during the investigation
- •Subject agrees to refrain from using other ear treatment products during the investigation
- •For pediatric patients, provision of informed consent by subject and legal -Subject, and if applicable legal representative(s), are willing to comply with the protocol and attend all investigation visits.
排除标准
- •Duration of OE signs/symptoms longer than 6 weeks
- •Suspected perforated eardrum or eardrum fitted with drainage tube
- •Post-mastoid surgery
- •Prior otologic surgery within 6 months of enrollment (must be successfully healed)
- •Conditions which may make it difficult to evaluate the therapeutic response (e.g malignant OE, abscess, granulation, polyps, congenital disorders)
- •History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiation therapy
- •Known allergy or sensitivity to any component of the device
- •Use of topical or systemic antibiotics, corticosteroids or other treatment that could affect the study result within 7 days prior to enrolment
- •Pregnancy or lactation at time of enrolment
- •Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
- •Participation in another clinical investigation within 30 days of screening
结局指标
主要结局
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
时间窗: Day 7
Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7
次要结局
- Change in Clinical Symptoms Itching, Otalgia and Tenderness(Change from Baseline (Day 1) to Day 7)
- Change in Microbes in the Earcanal(Change from Baseline (Day 1) to Day 7)
- Change of Moisture in the Earcanal(Change from Baseline (Day 1) to Day 7)
- Change in Volume of Ear Canal(Change from Baseline (Day 1) to Day 7)
- User Handling(Day 7)
- Change in Sleep(Change from Baseline (Day 1) to Day 7)
- Chnage in Pain Relief Medication Use(Change from Baseline (Day 1) to Day 7)
- Antibiotic Use(Day 7)
研究者
研究点 (3)
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