Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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.
Information provided by (Responsible Party):
Otic Pharma Identifier:
First received: May 20, 2011
Last updated: November 1, 2011
Last verified: November 2011
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 Intervention Phase
Otitis Externa
Otorhinolaryngologic Diseases
Ear Diseases
Drug: Ciprodex Otic Suspension
Drug: Ciprodexa Otic Foam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Otic Pharma:

Primary Outcome Measures:
  • 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:
  • 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] ]

Estimated Enrollment: 100
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01359098

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
Principal Investigator: Yehudah Roth, MD Edith Wolfson Medical Center
  More Information

Responsible Party: Otic Pharma Identifier: NCT01359098     History of Changes
Other Study ID Numbers: OP-003-000
Study First Received: May 20, 2011
Last Updated: November 1, 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:
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
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
Protease Inhibitors
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 processed this record on April 28, 2017