Clinical trial NCT05370209: Performance and Safety of Otinova® Ear Spray
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Otitis Externa
Lead sponsor: Circius Pharma AB
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
timeFrame: Day 7
Secondary outcomes:
measure: Change in Clinical Symptoms Itching, Otalgia and Tenderness
timeFrame: Change from Baseline (Day 1) to Day 7
measure: Change in Microbes in the Earcanal
timeFrame: Change from Baseline (Day 1) to Day 7
measure: Change of Moisture in the Earcanal
timeFrame: Change from Baseline (Day 1) to Day 7
measure: Change in Volume of Ear Canal
timeFrame: Change from Baseline (Day 1) to Day 7
measure: User Handling
timeFrame: Day 7
measure: Change in Sleep
timeFrame: Change from Baseline (Day 1) to Day 7
measure: Chnage in Pain Relief Medication Use
timeFrame: Change from Baseline (Day 1) to Day 7
measure: Antibiotic Use
timeFrame: Day 7
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Carlanderska sjukhuset
city: Linköping
country: Sweden
facility: Cordinator Medical Service AB
city: Malmö
country: Sweden
facility: Öron-Näsa-Hals-Center Malmö
Study officials:
affiliation: Cordinator Medical Service AB
name: Daniel Wilhelms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Öron-Näsa-Hals-Center Malmö
name: Sarah Ohlsson Maleki, MD
role: PRINCIPAL_INVESTIGATOR
References: