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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis

Intervention / Treatment
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* Drug: 0.3% Ciprofloxacin Ear Drops
* Drug: 0.3% Ciprofloxacin Foam Otic Cipro


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ciloxan Ear Drops<br>Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops | Drug: 0.3% Ciprofloxacin Ear Drops<br>* 4 gtt BID for 7 days.<br>* Other names: Cipro;|
| Experimental: Foam Otic Cipro<br>Patients randomized to this study arm will receive the experimental product | Drug: 0.3% Ciprofloxacin Foam Otic Cipro<br>* 1 application, BID for 7 days<br>* Other names: Cipro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (BID, for 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation