search
Back to results

Performance and Safety of Otinova® Ear Spray

Primary Purpose

Otitis Externa

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Otinova® Ear Spray
Sponsored by
Circius Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Externa

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Carlanderska sjukhusetRecruiting
  • Cordinator Medical Service ABRecruiting
  • Öron-Näsa-Hals-Center MalmöRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Otinova® Ear Spray

Arm Description

Otinova® Ear Spray 1-2 sprays, twice daily for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 in microbes in the earcanal
Change of pathologic microbes in the ear canal 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 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.
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
Change in sleep
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
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
Antibiotic use
Use of antibiotics for OE symptoms at Day 7

Full Information

First Posted
May 3, 2022
Last Updated
August 29, 2023
Sponsor
Circius Pharma AB
search

1. Study Identification

Unique Protocol Identification Number
NCT05370209
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circius Pharma AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Externa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Otinova® Ear Spray
Arm Type
Experimental
Arm Description
Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
Intervention Type
Device
Intervention Name(s)
Otinova® Ear Spray
Intervention Description
Ear spray
Primary Outcome Measure Information:
Title
Clinical cure of clinical signs swelling, erythema and otorrhea
Description
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
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Change in clinical symptoms itching, otalgia and tenderness
Description
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)
Time Frame
Change from Baseline (Day 1) to Day 7
Title
Change in microbes in the earcanal
Description
Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.
Time Frame
Change from Baseline (Day 1) to Day 7
Title
Change of moisture in the earcanal
Description
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.
Time Frame
Change from Baseline (Day 1) to Day 7
Title
Change in volume of ear canal
Description
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.
Time Frame
Change from Baseline (Day 1) to Day 7
Title
User handling
Description
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
Time Frame
Day 7
Title
Change in sleep
Description
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Time Frame
Change from Baseline (Day 1) to Day 7
Title
Chnage in pain relief medication use
Description
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
Time Frame
Change from Baseline (Day 1) to Day 7
Title
Antibiotic use
Description
Use of antibiotics for OE symptoms at Day 7
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Åhsberg
Phone
+46 72 555 0168
Email
nina.ahsberg@devicia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Wilhelms, MD, PhD
Organizational Affiliation
Cordinator Medical Service AB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Ohlsson Maleki, MD
Organizational Affiliation
Öron-Näsa-Hals-Center Malmö
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carlanderska sjukhuset
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Falkdahl
Phone
+46 31 819120
Email
Maria.Falkdahl@carlanderska.se
First Name & Middle Initial & Last Name & Degree
Cristina Ioanes, MD
First Name & Middle Initial & Last Name & Degree
Susanne Lindström, MD
Facility Name
Cordinator Medical Service AB
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Thorsén Yxne
Phone
0730-761621
Email
kim.thorsen-yxne@cordinator.se
First Name & Middle Initial & Last Name & Degree
Daniel Wilhelms, MD
Facility Name
Öron-Näsa-Hals-Center Malmö
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Larsson
Phone
040-98 50 85
Email
audionom@onhcenter.se
First Name & Middle Initial & Last Name & Degree
Sarah Ohlsson Maleki, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance and Safety of Otinova® Ear Spray

We'll reach out to this number within 24 hrs