Study Stopped
Management decision
Safety and Efficacy of Moxidex Otic
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 3, 2012
November 1, 2012
1.7 years
February 18, 2010
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Cure at End of Treatment
Day 8
Secondary Outcomes (2)
Time to Cessation of Otorrhea
From First Dose
Microbiological Success at End of Treatment
Day 8
Study Arms (3)
Moxidex
EXPERIMENTALMoxidex otic solution
Moxifloxacin
ACTIVE COMPARATORMoxifloxacin otic solution
Vehicle
PLACEBO COMPARATORVehicle
Interventions
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Contact Alcon Call Center
1-888-451-3937
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 19, 2010
Study Start
February 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 3, 2012
Record last verified: 2012-11