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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 (Once-a-day)

Primary Purpose

Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
0.3% Ciprofloxacin Ear Drops
FoamOtic Cipro
Sponsored by
Otic Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Wolfson Medical Center
  • Bet Roter Clinic, Clalit Health Services

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

First Posted
July 4, 2010
Last Updated
March 14, 2011
Sponsor
Otic Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01157819
Brief Title
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
Acronym
Once-a-day
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (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 (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.
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.

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (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 b.i.d. for 7 days.
Intervention Type
Drug
Intervention Name(s)
FoamOtic Cipro
Other Intervention Name(s)
Ciprofloxacin, Cipro
Intervention Description
0.3% Ciprofloxacin Otic Foam, 1 application, q.d. 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 that lasts 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
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Bet Roter Clinic, Clalit Health Services
City
Holon
ZIP/Postal Code
58320
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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