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Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Acute Otitis Externa Clinical Trial

Official title:
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Clinical Trial Summary

The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Clinical Trial Description

Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01535599
Study type Interventional
Source Alcon Research
Contact
Status Completed
Phase Phase 3
Start date March 2012
Completion date May 2013
View Details
See also
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Completed NCT03196973 - Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa Phase 3
Recruiting NCT01584271 - Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) Phase 2
Completed NCT02216071 - Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa Phase 3
Completed NCT00961675 - FST-201 in the Treatment of Acute Otitis Externa Phase 3
Completed NCT01535560 - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa Phase 3