Back to resultsSafety and Efficacy of Moxidex Otic
Primary Purpose
Acute Otitis Media
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Moxidex otic solution
Moxifloxacin otic solution
Vehicle
Tympanostomy tubes
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media focused on measuring ear tubes, ear drainage, ear infection, ear drops, acute otitis media
Eligibility Criteria
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
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Moxidex
Moxifloxacin
Vehicle
Arm Description
Moxidex otic solution
Moxifloxacin otic solution
Vehicle
Outcomes
Primary Outcome Measures
Clinical Cure at End of Treatment
Secondary Outcome Measures
Time to Cessation of Otorrhea
Microbiological Success at End of Treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01071902
Brief Title
Safety and Efficacy of Moxidex Otic
Official Title
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Management decision
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
Keywords
ear tubes, ear drainage, ear infection, ear drops, acute otitis media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxidex
Arm Type
Experimental
Arm Description
Moxidex otic solution
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Moxifloxacin otic solution
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Moxidex otic solution
Intervention Description
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin otic solution
Intervention Description
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Intervention Type
Device
Intervention Name(s)
Tympanostomy tubes
Intervention Description
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Primary Outcome Measure Information:
Title
Clinical Cure at End of Treatment
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Time to Cessation of Otorrhea
Time Frame
From First Dose
Title
Microbiological Success at End of Treatment
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contact Alcon Call Center
Organizational Affiliation
1-888-451-3937
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of Moxidex Otic
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