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

COMPLETEDPHASE1

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

An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

NCT02539654•Alcon Research

View on ClinicalTrials.gov

Summary

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

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;
•Legally Authorized Representative (LAR) must read and sign the informed consent;
•Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;

Exclusion Criteria

•Menarcheal females;
•Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
•Existing perforation of the eardrum;
•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;
•Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
•Weighs less than 8 kg;

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Key Dates

Start Date

November 17, 2015

Primary Completion Date

June 24, 2016

Completion Date

June 24, 2016

Last Updated

August 7, 2018

Enrollment

ACTUAL participants

Conditions

Otitis Media With Effusion in ChildrenOtitis Media Recurrent

Interventions

EXE844 Sterile Otic Suspension, 0.3%

DRUG

Tympanostomy Tube Insertion

PROCEDURE

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

NCT02432105

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: August 7, 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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