Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Primary Purpose
Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
0.3% Ciprofloxacin Ear Drops
0.3% Ciprofloxacin Foam Otic Cipro
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Externa focused on measuring swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
Eligibility 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.
Sites / Locations
- HaEmek Medical Center
- Wolfson Medical Center
- Maccabi Healthcare Services
- Assaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ciloxan Ear Drops
Foam Otic Cipro
Arm Description
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
Patients randomized to this study arm will receive the experimental product
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872209
Brief Title
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Official Title
Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otic Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
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. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis
Keywords
swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ciloxan Ear Drops
Arm Type
Active Comparator
Arm Description
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
Arm Title
Foam Otic Cipro
Arm Type
Experimental
Arm Description
Patients randomized to this study arm will receive the experimental product
Intervention Type
Drug
Intervention Name(s)
0.3% Ciprofloxacin Ear Drops
Other Intervention Name(s)
Ciloxan, Ciprofloxacin, Cipro
Intervention Description
4 gtt BID for 7 days.
Intervention Type
Drug
Intervention Name(s)
0.3% Ciprofloxacin Foam Otic Cipro
Other Intervention Name(s)
Ciloxan, Ciprofloxacin, Cipro
Intervention Description
1 application, BID for 7 days
Primary Outcome Measure Information:
Title
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
Time Frame
within 7 days after completion of treatment (BID, for 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehudah Roth, MD
Organizational Affiliation
Edith Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Maccabi Healthcare Services
City
Tel Aviv
ZIP/Postal Code
68125
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
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