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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Ear spray
Carlanderska sjukhuset
Gothenburg, Sweden
Cordinator Medical Service AB
Linköping, Sweden
Öron-Näsa-Hals-Center Malmö
Malmo, Sweden
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
Time frame: Day 7
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 7
Change in Sleep
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Time frame: 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
Time frame: Change from Baseline (Day 1) to Day 7
Antibiotic Use
Use of antibiotics for OE symptoms at Day 7
Time frame: Day 7