A 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: Drug: Moxidex otic solution; Drug: Ofloxacin otic solution; Device: Tympanostomy tubes

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578474

C-05-35

Details and patient eligibility

About

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.

Enrollment: 911 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 related
• 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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911 participants in 2 patient groups

Moxidex

Experimental group

Description:

Moxidex otic solution

Treatment:

Drug: Moxidex otic solution

Device: Tympanostomy tubes

FLOXIN

Active Comparator group

Description:

Ofloxacin otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Ofloxacin otic solution