Performance and Safety of Otinova® Ear Spray

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

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.

Study Overview

• Status: Recruiting
• Conditions: Otitis Externa
• Intervention / Treatment: Device: Otinova® Ear Spray

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina Åhsberg; Phone Number: +46 72 555 0168; Email: nina.ahsberg@devicia.com

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Carlanderska sjukhuset
    • Contact: Maria Falkdahl; Phone Number: +46 31 819120; Email: Maria.Falkdahl@carlanderska.se
    • Principal Investigator: Cristina Ioanes, MD
    • Sub-Investigator: Susanne Lindström, MD
  • Linköping, Sweden
    • Recruiting
    • Cordinator Medical Service AB
    • Contact: Kim Thorsén Yxne; Phone Number: 0730-761621; Email: kim.thorsen-yxne@cordinator.se
    • Principal Investigator: Daniel Wilhelms, MD
  • Malmö, Sweden
    • Recruiting
    • Öron-Näsa-Hals-Center Malmö
    • Contact: Kristina Larsson; Phone Number: 040-98 50 85; Email: audionom@onhcenter.se
    • Principal Investigator: Sarah Ohlsson Maleki, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otinova® Ear Spray; Otinova® Ear Spray 1-2 sprays, twice daily for 7 days	Device: Otinova® Ear Spray; Ear spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Antibiotic use	Use of antibiotics for OE symptoms at Day 7	Day 7

Collaborators and Investigators

• Sponsor: Circius Pharma AB
• Investigators: Principal Investigator: Daniel Wilhelms, MD, PhD, Cordinator Medical Service AB; Principal Investigator: Sarah Ohlsson Maleki, MD, Öron-Näsa-Hals-Center Malmö

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis
• Other Study ID Numbers: CIR_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No