Trials / Completed
CompletedNCT00578474
A 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
- 911 (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 an 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 | Ofloxacin otic solution | 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days |
| DEVICE | Tympanostomy tubes | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2007-12-21
- Last updated
- 2012-12-03
Source: ClinicalTrials.gov record NCT00578474. Inclusion in this directory is not an endorsement.