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

Phase 2

Completed

• Conditions: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
• Interventions: Drug: 0.3% Ciprofloxacin Ear Drops; Drug: FoamOtic Cipro

• Registration Number: NCT01157819
• Lead Sponsor: Otic Pharma

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 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. 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-04
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Aged 18 and older eligible to sign by themselves.
• Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
• Intact tympanic membrane
• Unilateral Acute Otitis Externa

Exclusion Criteria

• Known allergy or sensitivity to Ciprofloxacin or other quinolones.
• Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
• Patient has the non intact tympanic membrane.
• Patient has a serious underlying disease.
• Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
• Patients with history of Diabetes mellitus.
• Bilateral Acute Otitis Externa.
• Patients with more than 80% of the ear canal occluded.
• Pregnant or lactating patients.
• Overt fungal Acute Otitis Externa.
• Local ear canal abnormalities such as abscess, granulation or polyps.
• Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
• Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
• Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
• Current Infection requiring systemic antimicrobial therapy.
• Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciloxan Ear Drops	0.3% Ciprofloxacin Ear Drops	Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
Foam Otic Cipro	FoamOtic Cipro	Patients randomized to this study arm will receive the experimental product

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Bet Roter Clinic, Clalit Health Services; 🇮🇱 Holon, Israel

Wolfson Medical Center; 🇮🇱 Holon, Israel