A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

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

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: Moxidex otic solution
* Drug: Ofloxacin otic solution
* Device: Tympanostomy tubes


Participation Criteria
=================
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 Patient may not require any other systemic antimicrobial therapy during the study Patient must meet certain medication washouts to be eligible Analgesic use (other than acetaminophen) is not allowed Patient may not be pre-disposed to neurosensory hearing loss Other protocol-defined inclusion criteria may apply Exclusion Criteria: Age related Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidex<br>Moxidex otic solution | Drug: Moxidex otic solution<br>* 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days<br>Device: Tympanostomy tubes<br>* Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children<br>|
| Active Comparator: FLOXIN<br>Ofloxacin otic solution | Drug: Ofloxacin otic solution<br>* 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days<br>* Other names: FLOXIN;Device: Tympanostomy tubes<br>* Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate at the test of cure visit as determined by the investigator |  | From baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cessation of otorrhea |  | From baseline | 
| Microbiological outcome |  | From baseline | 
| Treatment failures |  | From baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute otitis media, Tympanostomy tubes