Performance and Safety of Otinova® Ear Spray (NCT05370209) | Clinical Trial Compass
TerminatedNot Applicable
Performance and Safety of Otinova® Ear Spray
Stopped: Slow recruitment
Sweden28 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea