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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otic Pharma
ClinicalTrials.gov Identifier:
NCT01359098
First received: May 20, 2011
Last updated: November 1, 2011
Last verified: November 2011

May 20, 2011
November 1, 2011
July 2011
October 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01359098 on ClinicalTrials.gov Archive Site
  • 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] ] [ Designated as safety issue: No ]
    Ear pain as reported by the patient
  • Inflammation/ear edema [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ] [ Designated as safety issue: No ]
  • Ear discharge/otorrhea [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ] [ Designated as safety issue: No ]
  • tenderness with movement of pinna [ Time Frame: At the test-of-cure visit [Day 8 - Day 14] ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
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

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Otitis Externa
  • Otorhinolaryngologic Diseases
  • Ear Diseases
  • Otitis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
3 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01359098
OP-003-000
No
Otic Pharma
Otic Pharma
Not Provided
Principal Investigator: Yehudah Roth, MD Edith Wolfson Medical Center
Otic Pharma
November 2011

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