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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872209
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : December 24, 2009
Information provided by:
Otic Pharma

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.

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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

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

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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872209

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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
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Principal Investigator: Yehudah Roth, MD Edith Wolfson Medical Center
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Responsible Party: Dr. Rodrigo Yelin (Study Director), Otic Pharma LTD Identifier: NCT00872209    
Other Study ID Numbers: OP-001-00
First Posted: March 31, 2009    Key Record Dates
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:
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Ear Diseases
Otitis Externa
Otorhinolaryngologic Diseases
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