Acute Otitis Media
Conditions
Keywords
ear tubes, ear drainage, ear infection, ear drops, acute otitis media
Brief summary
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.
Interventions
OTHERVehicle
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
DEVICETympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure at End of Treatment | Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cessation of Otorrhea | From First Dose |
| Microbiological Success at End of Treatment | Day 8 |
Countries
United States
Outcome results
None listed