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

Otic Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ear Diseases

Otorhinolaryngologic Diseases

Otitis

Otitis Externa

Treatments

Drug: 0.3% Ciprofloxacin Ear Drops

Drug: 0.3% Ciprofloxacin Foam Otic Cipro

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872209

OP-001-00

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.