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Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion

NCT02432105•Alcon Research

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Eligibility

Age

0 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
•Suspected bacterial infection at time of surgery in at least 1 ear.
•Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
•Legally Authorized Representative (LAR) must read and sign the informed consent.
•Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.

Exclusion Criteria

•Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
•Middle ear pathology in either ear other than otitis media.
•Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
•Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
•Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.

Key Dates

Start Date

June 25, 2015

Primary Completion Date

June 15, 2016

Completion Date

June 15, 2016

Last Updated

July 2, 2018

Enrollment

470

ACTUAL participants

Conditions

Otitis Media With Effusion in ChildrenOtitis Media Recurrent

Interventions

EXE844 Sterile Otic Suspension, 0.3%

DRUG

Tympanostomy Tube Insertion

PROCEDURE

Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

NCT02539654

Otitis Media With Effusion in ChildrenOtitis Media Recurrent

View study

COMPLETEDPHASE3

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

NCT02436304

Otitis Media With Effusion in ChildrenOtitis Media Recurrent

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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