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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

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

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

NCT ID

NCT00872209

First Posted

March 29, 2009

Last Updated

December 23, 2009

Sponsor

Otic Pharma

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

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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