Performance and Safety of Otinova® Ear Spray

Otitis Externa Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370209
• Other study ID #: CIR_001
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Circius Pharma AB
• Contact: Nina Åhsberg
• Phone: +46 72 555 0168
• Email: nina.ahsberg[@]devicia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Externa

Intervention

Device:
• Otinova® Ear Spray
Ear spray

Locations

Country	Name	City	State
Sweden	Carlanderska sjukhuset	Gothenburg
Sweden	Cordinator Medical Service AB	Linköping
Sweden	Öron-Näsa-Hals-Center Malmö	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Circius Pharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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)	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.	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.	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.	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	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	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	Change from Baseline (Day 1) to Day 7
Secondary	Antibiotic use	Use of antibiotics for OE symptoms at Day 7	Day 7