Performance and Safety of Otinova® Ear Spray
- Conditions
- Otitis Externa
- Interventions
- Device: Otinova® Ear Spray
- Registration Number
- NCT05370209
- Lead Sponsor
- Circius Pharma AB
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
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Male or female ≥ 5 years old
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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)
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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
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Subject agrees to refrain from using other ear treatment products during the investigation
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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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Otinova® Ear Spray Otinova® Ear Spray Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
- Primary Outcome Measures
Name Time Method Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea 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
- Secondary Outcome Measures
Name Time Method Change in Clinical Symptoms Itching, Otalgia and Tenderness Change from Baseline (Day 1) to Day 7 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 in Microbes in the Earcanal Change from Baseline (Day 1) to Day 7 Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.
Change of Moisture in the Earcanal Change from Baseline (Day 1) to Day 7 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 in Volume of Ear Canal Change from Baseline (Day 1) to Day 7 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.
User Handling Day 7 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
Change in Sleep Change from Baseline (Day 1) to Day 7 Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Chnage in Pain Relief Medication Use Change from Baseline (Day 1) to Day 7 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
Antibiotic Use Day 7 Use of antibiotics for OE symptoms at Day 7
Trial Locations
- Locations (3)
Carlanderska sjukhuset
🇸🇪Gothenburg, Sweden
Öron-Näsa-Hals-Center Malmö
🇸🇪Malmö, Sweden
Cordinator Medical Service AB
🇸🇪Linköping, Sweden