NCT00872209

Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa

Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Otic Pharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin. The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.

Detailed description

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. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. 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.

Conditions

• Otitis Externa
• Otorhinolaryngologic Diseases
• Ear Diseases
• Otitis

Interventions

Type	Name	Description
DRUG	0.3% Ciprofloxacin Ear Drops	4 gtt BID for 7 days.
DRUG	0.3% Ciprofloxacin Foam Otic Cipro	1 application, BID for 7 days

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2009-03-31
• Last updated: 2009-12-24

Locations

4 sites across 1 country: Israel