Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro (0.3% Ciprofloxacin Otic Foam) Compared to Twice-Daily Dosing of Ciloxan (0.3% Ciprofloxacin Otic Solution) in Patients With Acute External Otitis (Once-a-day)

NCT01157819 Phase 2 COMPLETED

The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.

Details

Lead sponsor	Otic Pharma
Phase	Phase 2
Status	COMPLETED
Enrolment	70
Start date	2010-07
Completion	2010-12

Conditions

• Otitis Externa
• Otorhinolaryngologic Diseases
• Ear Diseases
• Otitis

Interventions

• 0.3% Ciprofloxacin Ear Drops
• FoamOtic Cipro

Primary outcomes

• Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion — within 7 days after completion of treatment that lasts 7 days

Countries

Israel