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

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578474

Enrollment

911

Registered

2007-12-21

Start date

2005-12-31

Completion date

2008-08-31

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media

Keywords

Acute otitis media, Tympanostomy tubes

Brief summary

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.

Interventions

DRUGMoxidex otic solution

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

DRUGOfloxacin otic solution

5 drops into the infected ear(s) twice daily (morning and evening) for 10 days

DEVICETympanostomy tubes

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

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

Design outcomes

Primary

Measure	Time frame
Clinical cure rate at the test of cure visit as determined by the investigator	From baseline

Secondary

Measure	Time frame
Time to cessation of otorrhea	From baseline
Microbiological outcome	From baseline
Treatment failures	From baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026