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

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Ear Disorders

Drug Information available for: Carbamide Carbamide peroxide Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Otic Pharma:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2009
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872209

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

No publications provided

Responsible Party:	Dr. Rodrigo Yelin (Study Director), Otic Pharma LTD
ClinicalTrials.gov Identifier:	NCT00872209 History of Changes
Other Study ID Numbers:	OP-001-00
Study First Received:	March 29, 2009
Last Updated:	December 23, 2009
Health Authority:	Israel: Ministry of Health

Keywords provided by Otic Pharma:

swimmer's ear
ear drops
ear foam
otic foam

ear infection
ear pain
ear inflammation

Additional relevant MeSH terms:

Ear Diseases
Otitis Externa
Otitis
Otorhinolaryngologic Diseases
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013