NCT05370209

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

May 3, 2022

Results QC Date

August 6, 2024

Last Update Submit

September 10, 2024

Conditions

Otitis Externa

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in Clinical Symptoms Itching, Otalgia and Tenderness

    Change from Baseline (Day 1) to Day 7

  • Change in Microbes in the Earcanal

    Change from Baseline (Day 1) to Day 7

  • Change of Moisture in the Earcanal

    Change from Baseline (Day 1) to Day 7

  • Change in Volume of Ear Canal

    Change from Baseline (Day 1) to Day 7

  • User Handling

    Day 7

  • +3 more secondary outcomes

Study Arms (1)

Otinova® Ear Spray

EXPERIMENTAL

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

Device: Otinova® Ear Spray

Interventions

Otinova® Ear SprayDEVICE

Ear spray

Otinova® Ear Spray

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Carlanderska sjukhuset

Gothenburg, Sweden

Location

Cordinator Medical Service AB

Linköping, Sweden

Location

Öron-Näsa-Hals-Center Malmö

Malmo, Sweden

Location

MeSH Terms

Conditions

Otitis Externa

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Limitations and Caveats

Early termination due to slow recruitment

Results Point of Contact

Title
Maria Carlsson
Organization
Circius Pharma AB
RAQA@circiuspharma.com
+46 (0) 31-81 84 00

Study Officials

  • Daniel Wilhelms, MD, PhD

    Cordinator Medical Service AB

    PRINCIPAL INVESTIGATOR

  • Sarah Ohlsson Maleki, MD

    Öron-Näsa-Hals-Center Malmö

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 11, 2022

Study Start

May 1, 2022

Primary Completion

November 27, 2023

Study Completion

January 29, 2024

Last Updated

November 15, 2024

Results First Posted

November 15, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)