Clinical Trial: Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 O

Brief Summary: 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.

Detailed Summary: Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.
Sponsor: Otic Pharma

Current Primary Outcome: 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 [ Time Frame: within 7 days after completion of treatment that lasts 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otic Pharma

Dates:
Date Received: July 4, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 14, 2011
Last Verified: March 2011