A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Study Overview
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Brief Summary
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The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.

Official Title
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Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea

Conditions
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Acute Otitis Media

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months to 12 years old Diagnosed with recurrent acute otitis media or chronic otitis media with effusion Must be first set of ear tubes. Patient may not have had any other previous otologic-related surgery. Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube Patient may not have existing perforation of the eardrum. Patient must not require another surgical procedure other than myringotomy and tube insertion. 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 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: Single


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>|
| Other: TT only<br>Tympanostomy tubes only | 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 |
| --- | --- | --- |
| Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary |  | From baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cures at each visit |  | From baseline | 
| Absence of otorrhea at each visit |  | From baseline | 

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