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

NCT ID: NCT00872209

Last Updated: 2009-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciloxan Ear Drops

Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops

Group Type: ACTIVE_COMPARATOR

0.3% Ciprofloxacin Ear Drops

Intervention Type: DRUG

4 gtt BID for 7 days.

Foam Otic Cipro

Patients randomized to this study arm will receive the experimental product

Group Type: EXPERIMENTAL

0.3% Ciprofloxacin Foam Otic Cipro

Intervention Type: DRUG

1 application, BID for 7 days

Interventions

0.3% Ciprofloxacin Ear Drops

4 gtt BID for 7 days.

Intervention Type: DRUG

0.3% Ciprofloxacin Foam Otic Cipro

1 application, BID for 7 days

Intervention Type: DRUG

Other Intervention Names

Ciloxan; Ciprofloxacin; Cipro; Ciloxan; Ciprofloxacin; Cipro

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otic Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Otic Pharma LTD

Principal Investigators

Yehudah Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

HaEmek Medical Center

Afula, , Israel

Wolfson Medical Center

Holon, , Israel

Maccabi Healthcare Services

Tel Aviv, , Israel

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Other Identifiers

OP-001-00

Identifier Type: -

Identifier Source: org_study_id