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Trial record 3 of 3 for:    "Otic Pharma"

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

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.

Condition or disease Intervention/treatment Phase
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis Drug: Ciprodex Otic Suspension Drug: Ciprodexa Otic Foam 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 (otorrhea).

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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: 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
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ciprodex Otic Suspension
Ciprodex Sterile Otic Solution (Alcon, Inc.)
Drug: Ciprodex Otic Suspension
4 gtt b.i.d. for 7 days.
Other Names:
  • Ciprodex
  • Ciprodex b.i.d.

Experimental: Ciprodexa Otic Foam
Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Inflammation/ear edema [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ]
  3. Ear discharge/otorrhea [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ]
  4. tenderness with movement of pinna [ Time Frame: At the test-of-cure visit [Day 8 - Day 14] ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT01359098

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HaEmek Medical Center
Afula, Israel
Soroka Medical Center
Beer Sheva, Israel
Wolfson Medical Center
Holon, Israel, 58100
Meir Medical Center
Kfar Saba, Israel
Clalit Health Services - Raziel Clinic
Natania, Israel
Maccabi Healthcare Services (H.M.O.)
Tel Aviv, Israel
Sourasky Medical Center (Ichilov)
Tel Aviv, Israel
Sponsors and Collaborators
Otic Pharma
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Principal Investigator: Yehudah Roth, MD Edith Wolfson Medical Center
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Responsible Party: Otic Pharma Identifier: NCT01359098    
Other Study ID Numbers: OP-003-000
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 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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Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors