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

• ClinicalTrials.gov Identifier: NCT00872209
• Recruitment Status: Completed
• First Posted: March 31, 2009
• Last Update Posted: December 24, 2009
• Sponsor: Otic Pharma
• Information provided by: Otic Pharma

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis	Drug: 0.3% Ciprofloxacin Ear Drops; Drug: 0.3% Ciprofloxacin Foam Otic Cipro	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: May 2009
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ciloxan Ear Drops; Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops	Drug: 0.3% Ciprofloxacin Ear Drops; 4 gtt BID for 7 days.; Other Names: Ciloxan; Ciprofloxacin; Cipro
Experimental: Foam Otic Cipro; Patients randomized to this study arm will receive the experimental product	Drug: 0.3% Ciprofloxacin Foam Otic Cipro; 1 application, BID for 7 days; Other Names: Ciloxan; Ciprofloxacin; Cipro

Outcome Measures

Primary Outcome Measures :

1. 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 (BID, for 7 days) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Israel

HaEmek Medical Center

Afula, Israel

Wolfson Medical Center

Holon, Israel, 58100

Maccabi Healthcare Services

Tel Aviv, Israel, 68125

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Sponsors and Collaborators

Otic Pharma

Investigators

• Principal Investigator: Yehudah Roth, MD; Edith Wolfson Medical Center

More Information

• Responsible Party: Dr. Rodrigo Yelin (Study Director), Otic Pharma LTD
• ClinicalTrials.gov Identifier: NCT00872209
• Other Study ID Numbers: OP-001-00
• First Posted: March 31, 2009
• Last Update Posted: December 24, 2009
• Last Verified: December 2009

Keywords provided by Otic Pharma:

swimmer's ear; ear drops; ear foam; otic foam; ear infection; ear pain; ear inflammation

Additional relevant MeSH terms:

Otitis; Ear Diseases; Otitis Externa; Otorhinolaryngologic Diseases; Ciprofloxacin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors