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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00578474 |
The purpose of this study is to determine if AL-15469A / AL-38905 is safe and effective in treating middle ear infections in patients with ear tubes.
Condition | Intervention | Phase |
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Acute Otitis Media With Tympanostomy Tubes |
Drug: AL-15469A / AL-38905 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT) |
Estimated Enrollment: | 800 |
Study Start Date: | December 2005 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
ofloxacin 0.3%
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Drug: AL-15469A / AL-38905
Ear drops
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1: Active Comparator
AL-15469A/AL-38905
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Drug: AL-15469A / AL-38905
Ear drops
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Ages Eligible for Study: | 6 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Alcon ( Sheryl Dupree ) |
Study ID Numbers: | C-05-35 |
Study First Received: | December 19, 2007 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00578474 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Otorhinolaryngologic Diseases Otitis Otitis Media Ear Diseases |
Otorhinolaryngologic Diseases Otitis Otitis Media Ear Diseases |