Back to resultsA Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Primary Purpose
Acute Otitis Media
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Moxidex otic solution
Moxifloxacin otic solution
Tympanostomy tubes
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media focused on measuring ear tubes, ear infection, ear drops, ear tube surgery, acute otitis media
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Moxidex
Moxifloxacin
TT only
Arm Description
Moxidex otic solution
Moxifloxacin otic solution
Tympanostomy tubes only
Outcomes
Primary Outcome Measures
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
Secondary Outcome Measures
Clinical cures at each visit
Absence of otorrhea at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00578773
Brief Title
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Official Title
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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 an otic formulation is safe and effective in treating peri-operative tube otorrhea.
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 infection, ear drops, ear tube surgery, acute otitis media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
303 (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
TT only
Arm Type
Other
Arm Description
Tympanostomy tubes only
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
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
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
Time Frame
From baseline
Secondary Outcome Measure Information:
Title
Clinical cures at each visit
Time Frame
From baseline
Title
Absence of otorrhea at each visit
Time Frame
From baseline
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 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
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
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
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