Trials / Completed
CompletedNCT01535560
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 589 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
Detailed description
Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL-60371, 0.3% otic suspension | Investigational otic suspension intended for the treatment of acute otitis externa |
| DRUG | AL-60371 Vehicle | Inactive ingredients used as placebo |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2012-02-17
- Last updated
- 2013-12-10
- Results posted
- 2013-12-10
Source: ClinicalTrials.gov record NCT01535560. Inclusion in this directory is not an endorsement.