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Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis (Once-a-day)

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: NCT01157819
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : March 15, 2011
Information provided by:
Otic Pharma

Brief Summary:
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.

Condition or disease Intervention/treatment Phase
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis Drug: 0.3% Ciprofloxacin Ear Drops Drug: FoamOtic Cipro 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. 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 : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro (0.3% Ciprofloxacin Otic Foam) Compared to Twice-Daily Dosing of Ciloxan (0.3% Ciprofloxacin Otic Solution) in Patients With Acute External Otitis
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ciloxan Ear Drops
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
Drug: 0.3% Ciprofloxacin Ear Drops
4 gtt b.i.d. for 7 days.
Other Names:
  • Ciloxan
  • Ciprofloxacin
  • Cipro

Experimental: Foam Otic Cipro
Patients randomized to this study arm will receive the experimental product
Drug: FoamOtic Cipro
0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days
Other Names:
  • 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 that lasts 7 days ]

Information from the National Library of Medicine

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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): NCT01157819

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Wolfson Medical Center
Holon, Israel, 58100
Bet Roter Clinic, Clalit Health Services
Holon, Israel, 58320
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: NCT01157819    
Other Study ID Numbers: OP-002-000
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011
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