MedTrace Logo

A Phase III Study of an Otic Formulation in Acute Otitis Externa

NCT00750633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 990

Last updated 2012-12-03

No results posted yet for this study

Summary

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

Conditions

  • Acute Otitis Externa

Interventions

DRUG

Moxidex otic solution

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

DRUG

Moxifloxacin otic solution

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

DRUG

Dexamethasone phosphate otic solution

4 drops in 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 with effusion 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

More Related Trials

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 NCT00750633 on ClinicalTrials.gov