Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT01535560
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: