Performance and Safety of Otinova® Ear Spray

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Otitis Externa

Intervention / Treatment
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* Device: Otinova® Ear Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otinova® Ear Spray<br>Otinova® Ear Spray 1-2 sprays, twice daily for 7 days | Device: Otinova® Ear Spray<br>* Ear spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure of clinical signs swelling, erythema and otorrhea | 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 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms itching, otalgia and tenderness | Change in clinical symptoms itching, otalgia and tenderness, from Day 1 to Day 7, based on subject reported outcomes, using a score from 0 to 4, where 0 = no symptoms, 1= Mild, 2 = Moderate, 3= Severe and 4 = Very Severe) | Change from Baseline (Day 1) to Day 7 | 
| Change in microbes in the earcanal | Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7. | Change from Baseline (Day 1) to Day 7 | 
| Change of moisture in the earcanal | Proportion of subjects who have signs of otorrhea (moisture) at baseline (Day 1)on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7. | Change from Baseline (Day 1) to Day 7 | 
| Change in volume of ear canal | Proportion of subjects who have signs of swelling at baseline (Day 1) on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7. | Change from Baseline (Day 1) to Day 7 | 
| User handling | Questionnaire regarding User handling - How did you experience the use of the earspray? and Was it easy to apply the spray correctly in the ear? using a 5-point scale: 1=very easy to use, 2=easy to use, 3=neither easy nor difficult to use, 4=difficult to use, 5=very difficult to use | Day 7 | 
| Change in sleep | Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary | Change from Baseline (Day 1) to Day 7 | 
| Chnage in pain relief medication use | Proportion of subjects with less use of pain relief medication for ear pain on Day 7 compared to baseline (Day 1), as reported in subject diary | Change from Baseline (Day 1) to Day 7 | 
| Antibiotic use | Use of antibiotics for OE symptoms at Day 7 | Day 7 |