Safety and Efficacy of Moxidex Otic

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

Official Title
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Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: Moxidex otic solution
* Drug: Moxifloxacin otic solution
* Other: Vehicle
* Device: Tympanostomy tubes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months to 12 years of age Ear tubes in one or both ears Ear drainage visible by parent/guardian Ear drainage less than 21 days Other protocol-defined inclusion criteria may apply Exclusion Criteria: Patients not otorrhea-free for 7 or less following tympanostomy tube surgery Ear tube with antimicrobial activity; ear tube longer than 2.5mm Non-tube otorrhea No otic surgery other than tube placement in the last year No menarchial females; no diabetic patients No patients with any disease or condition that would negatively affect the conduct of the study No patients taking 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 Patients may not be predisposed to neurosensory hearing loss Other protocol-defined exclusion criteria may apply

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


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: Moxifloxacin<br>Moxifloxacin otic solution | Drug: Moxifloxacin 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>|
| Placebo Comparator: Vehicle<br>Vehicle | Other: Vehicle<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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure at End of Treatment |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cessation of Otorrhea |  | From First Dose | 
| Microbiological Success at End of Treatment |  | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ear tubes, ear drainage, ear infection, ear drops, acute otitis media