Trials / Terminated
TerminatedNCT01071902
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (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 Moxidex otic solution 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 |
| OTHER | Vehicle | 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
- 2010-02-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-02-19
- Last updated
- 2012-12-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01071902. Inclusion in this directory is not an endorsement.