A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media
Intervention: Moxidex otic solution (Drug); Ofloxacin otic solution (Drug); Tympanostomy tubes (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Contact Alcon Call Center, Study Director, Affiliation: 1-888-451-3937
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.
Clinical Details
Official title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical cure rate at the test of cure visit as determined by the investigator
Secondary outcome: Time to cessation of otorrheaMicrobiological outcome Treatment failures
Eligibility
Minimum age: 6 Months.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: December 2005
Last updated: November 29, 2012
|