Performance and Safety of Otinova® Ear Spray

Circius Pharma

Status

Terminated

Conditions

Otitis Externa

Treatments

Device: Otinova® Ear Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT05370209

CIR_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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