Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Alcon Research0 sites776 target enrollmentJanuary 2006

ConditionsAcute Otitis Media

InterventionsMoxidex otic solution Tympanostomy tubes Moxifloxacin otic solution

DrugsMoxidex otic solution Moxifloxacin otic solution

Overview

Phase: Phase 3
Intervention: Moxidex otic solution
Conditions: Acute Otitis Media
Sponsor: Alcon Research
Enrollment: 776
Primary Endpoint: Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

January 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•6 months to 12 years old
•Ear tubes in one or both ears
•Ear drainage visible by the parent / guardian
•Ear drainage less than 21 days
•Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
•Patient may not have non-tube otorrhea
•Patient may not have had otic surgery other than tube placement in the last year
•Patient may not be a menarchal female
•Diabetic patients are not eligible
•Patient may not have any disease or condition that would negatively affect the conduct of the study