Trials / Completed
CompletedNCT00750633
A Phase III Study of an Otic Formulation in Acute Otitis Externa
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 990 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Moxidex otic solution | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| DRUG | Moxifloxacin otic solution | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| DRUG | Dexamethasone phosphate otic solution | 4 drops in 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 with effusion in children |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2008-09-10
- Last updated
- 2012-12-03
Source: ClinicalTrials.gov record NCT00750633. Inclusion in this directory is not an endorsement.