Trials / Completed
CompletedNCT00579189
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 776 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Moxidex otic solution | 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days |
| DRUG | Moxifloxacin otic solution | 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days |
| DEVICE | Tympanostomy tubes | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2007-12-21
- Last updated
- 2012-12-03
Source: ClinicalTrials.gov record NCT00579189. Inclusion in this directory is not an endorsement.