A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Phase 2

Completed

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

• Registration Number: NCT00578773
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-28
• Disposition First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Disposition First Posted: 2012-12-03
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• 6 months to 12 years old
• Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
• Must be first set of ear tubes.
• Patient may not have had any other previous otologic-related surgery.
• Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
• Patient may not have existing perforation of the eardrum.
• Patient must not require another surgical procedure other than myringotomy and tube insertion.
• Patient may not be a menarchal female
• Diabetic patients are not eligible
• Patient may not have any disease or condition that would negatively affect the conduct of the study
• Patient may not require 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
• Patient may not be pre-disposed to neurosensory hearing loss
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Age
• 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
TT only	Tympanostomy tubes	Tympanostomy tubes only

Primary Outcome Measures

Name	Time	Method
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary	From baseline

Secondary Outcome Measures

Name	Time	Method
Clinical cures at each visit	From baseline
Absence of otorrhea at each visit	From baseline