Performance and Safety of Otinova® Ear Spray

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media

NCT03766373

Acute Otitis Media

COMPLETED PHASE1

Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.

NCT00967317

Otitis Efficacy Tolerability

UNKNOWN PHASE3

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

NCT03534219

Recurrent Acute Otitis Media Acute Otitis Media

WITHDRAWN NA

OTO-313 in Subjects With Subjective Tinnitus

NCT03918109

Tinnitus, Subjective

COMPLETED PHASE1/PHASE2

Effect of Simethicone on Eustachian Tube Dysfunction

NCT01312038

Otitis Media

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Otitis Externa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Otinova® Ear Spray

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

Group Type EXPERIMENTAL

Otinova® Ear Spray

Intervention Type DEVICE

Ear spray

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Otinova® Ear Spray

Ear spray

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No