Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
Abstract
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.
Conditions: Acute Otitis Media.
Primary outcome: Clinical cure rate at the test of cure visit as determined by the investigator.
Enrollment: 911 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 911 participants or records.
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