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Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa (Ciprodexa Foam)

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: NCT01359098
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Otic Pharma

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE May 24, 2011
Last Update Posted Date November 2, 2011
Study Start Date  ICMJE July 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Clinical cure [lack of need of additional therapy] [ Time Frame: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days ]
Clinical cure [lack of need of additional therapy] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Otalgia/ear pain [ Time Frame: At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14] ]
    Ear pain as reported by the patient
  • Inflammation/ear edema [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ]
  • Ear discharge/otorrhea [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ]
  • tenderness with movement of pinna [ Time Frame: At the test-of-cure visit [Day 8 - Day 14] ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
Official Title  ICMJE Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa
Brief Summary The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
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 (otorrhea).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Otitis Externa
  • Otorhinolaryngologic Diseases
  • Ear Diseases
  • Otitis
Intervention  ICMJE
  • Drug: Ciprodex Otic Suspension
    4 gtt b.i.d. for 7 days.
    Other Names:
    • Ciprodex
    • Ciprodex b.i.d.
  • Drug: Ciprodexa Otic Foam
    0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
    Other Names:
    • Ciprofloxacin, Dexamethasone Otic Foam
    • Ciprodexa foam once-a-day
Study Arms  ICMJE
  • Active Comparator: Ciprodex Otic Suspension
    Ciprodex Sterile Otic Solution (Alcon, Inc.)
    Intervention: Drug: Ciprodex Otic Suspension
  • Experimental: Ciprodexa Otic Foam
    Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)
    Intervention: Drug: Ciprodexa Otic Foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 3 years to 80 years old.
  • Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
  • Intact tympanic membrane
  • Unilateral disease

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01359098
Other Study ID Numbers  ICMJE OP-003-000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otic Pharma
Study Sponsor  ICMJE Otic Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yehudah Roth, MD Edith Wolfson Medical Center
PRS Account Otic Pharma
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP