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
Information source: Otic Pharma
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
Intervention: 0.3% Ciprofloxacin Ear Drops (Drug); FoamOtic Cipro (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Otic Pharma Official(s) and/or principal investigator(s):
Yehudah Roth, MD, Principal Investigator, Affiliation: Edith Wolfson Medical Center
Overall contact:
Rodrigo A Yelin, PhD, Phone: +972 54 5960199, Email: rodrigo.yelin@oticpharma.com
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.
Clinical Details
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 design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Rodrigo A Yelin, PhD, Phone: +972 54 5960199, Email: rodrigo.yelin@oticpharma.com
Wolfson Medical Center, Holon 58100, Israel; Recruiting
Yehudah Roth, MD, Phone: +972-3-5028651, Email: orl@wolfson.health.gov.il
Tal Marom, MD, Phone: +972 57 8170575, Email: maromtal@013.net.il
Yehudah Roth, MD, Principal Investigator
Marom Tal, MD, Sub-Investigator
Avraham Goldfarb, MD, Sub-Investigator
Maxim Sokolov, MD, Sub-Investigator
Eyal Russo, MD, Sub-Investigator
Dalia Levy, MD, Sub-Investigator
Udi Cinamon, MD, Sub-Investigator
Haim Flaksman, MD, Sub-Investigator
Yahav Oron, MD, Sub-Investigator
Sagit Shushan, MD, Sub-Investigator
Inbal Weiss, MD, Sub-Investigator
Assaf Len, MD, Sub-Investigator
Mazen Kazlak, MD, Sub-Investigator
Bet Roter Clinic, Clalit Health Services, Holon 58320, Israel; Recruiting
Ester Elad, MD, Phone: +972-54-4441281, Email: anneal@clalit.org.il
Yehudah Roth, MD, Phone: +972 3 5208651, Email: orl@wolfson.health.gov.il
Ester Elad, MD, Principal Investigator
Yehudah Roth, MD, Sub-Investigator
Julia Temin, MD, Sub-Investigator
Galina Idelson- Shavelzon, MD, Sub-Investigator
Marom Tal, MD, Sub-Investigator
Avraham Goldfarb, MD, Sub-Investigator
Maxim Sokolov, MD, Sub-Investigator
Eyal Russo, MD, Sub-Investigator
Dalia Levy, MD, Sub-Investigator
Udi Cinamon, MD, Sub-Investigator
Haim Flaksman, MD, Sub-Investigator
Yahav Oron, MD, Sub-Investigator
Sagit Shushan, MD, Sub-Investigator
Additional Information
Starting date: July 2010
Last updated: July 7, 2010
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