Otitis Externa
Conditions
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.
Interventions
DEVICEOtinova® Ear Spray
Ear spray
Sponsors
Circius Pharma AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
| 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 |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Otinova® Ear Spray Otinova® Ear Spray 1-2 sprays, twice daily for 7 days | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Otinova® Ear Spray | — |
|---|---|---|
| Age, Customized >18 | 26 Participants | — |
| Age, Customized 5-17 | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 28 participants | — |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 4 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Otinova® Ear Spray | Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea | 28 Participants |
Secondary
Antibiotic Use
Use of antibiotics for OE symptoms at Day 7
Time frame: Day 7
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Time frame: Day 7