Safety and Efficacy of Moxidex Otic

Phase 3

Terminated

• Conditions: Acute Otitis Media
• Interventions: Drug: Moxidex otic solution; Drug: Moxifloxacin otic solution; Other: Vehicle; Device: Tympanostomy tubes

• Registration Number: NCT01071902
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-28
• Disposition First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-29
• Disposition First Posted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 6 months to 12 years of age
• Ear tubes in one or both ears
• Ear drainage visible by parent/guardian
• Ear drainage less than 21 days
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
• Ear tube with antimicrobial activity; ear tube longer than 2.5mm
• Non-tube otorrhea
• No otic surgery other than tube placement in the last year
• No menarchial females; no diabetic patients
• No patients with any disease or condition that would negatively affect the conduct of the study
• No patients taking 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
• Patients may not be predisposed to neurosensory hearing loss
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxidex	Moxidex otic solution	Moxidex otic solution
Moxidex	Tympanostomy tubes	Moxidex otic solution
Moxifloxacin	Moxifloxacin otic solution	Moxifloxacin otic solution
Moxifloxacin	Tympanostomy tubes	Moxifloxacin otic solution
Vehicle	Vehicle	Vehicle
Vehicle	Tympanostomy tubes	Vehicle

Primary Outcome Measures

Name	Time	Method
Clinical Cure at End of Treatment	Day 8

Secondary Outcome Measures

Name	Time	Method
Time to Cessation of Otorrhea	From First Dose
Microbiological Success at End of Treatment	Day 8

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States