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

Alcon

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Media

Treatments: Device: Tympanostomy tubes; Drug: Moxidex otic solution; Drug: Moxifloxacin otic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00579189

C-05-36

Details and patient eligibility

About

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.

Enrollment: 776 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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776 participants in 2 patient groups

Moxidex

Experimental group

Description:

Moxidex otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Moxidex otic solution

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Moxifloxacin otic solution