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Safety and Efficacy of Moxidex Otic

NCT01071902 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-12-03

No results posted yet for this study

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.

Conditions

  • Acute Otitis Media

Interventions

DRUG

Moxidex otic solution

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

DRUG

Moxifloxacin otic solution

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

OTHER

Vehicle

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

DEVICE

Tympanostomy tubes

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Contact Alcon Call Center · 1-888-451-3937

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01071902 on ClinicalTrials.gov