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

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.

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.

Study Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis
• Intervention / Treatment: Drug: 0.3% Ciprofloxacin Ear Drops; Drug: 0.3% Ciprofloxacin Foam Otic Cipro

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Haemek Medical Center
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Tel Aviv, Israel, 68125
    • Maccabi Healthcare Services
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Otic Pharma
• Investigators: Principal Investigator: Yehudah Roth, MD, Edith Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: March 29, 2009
• First Submitted That Met QC Criteria: March 29, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): December 24, 2009
• Last Update Submitted That Met QC Criteria: December 23, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: ear infection; swimmer's ear; ear drops; ear foam; otic foam; ear pain; ear inflammation
• Additional Relevant MeSH Terms: Otitis Externa; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: OP-001-00