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Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

NCT01027494 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 318

Last updated 2013-03-18

No results posted yet for this study

Summary

The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.

Conditions

  • Acute Otitis Media

Interventions

DRUG

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension

Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Gale Cupp, MS · Alcon Research

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027494 on ClinicalTrials.gov