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Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa (Ciprodexa Foam)

Primary Purpose

Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Ciprodex Otic Suspension

Ciprodexa Otic Foam

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

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

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.

Sites / Locations

HaEmek Medical Center
Soroka Medical Center
Wolfson Medical Center
Meir Medical Center
Clalit Health Services - Raziel Clinic
Maccabi Healthcare Services (H.M.O.)
Sourasky Medical Center (Ichilov)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ciprodex Otic Suspension

Ciprodexa Otic Foam

Arm Description

Ciprodex Sterile Otic Solution (Alcon, Inc.)

Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)

Outcomes

Primary Outcome Measures

Clinical cure [lack of need of additional therapy]

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

Ear pain as reported by the patient

Inflammation/ear edema

Ear discharge/otorrhea

tenderness with movement of pinna

Full Information

NCT ID

NCT01359098

First Posted

May 20, 2011

Last Updated

November 1, 2011

Sponsor

Otic Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01359098

Brief Title

Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

Acronym

Ciprodexa Foam

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otic Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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).

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

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ciprodex Otic Suspension

Arm Type

Active Comparator

Arm Description

Ciprodex Sterile Otic Solution (Alcon, Inc.)

Arm Title

Ciprodexa Otic Foam

Arm Type

Experimental

Arm Description

Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)

Intervention Type

Drug

Intervention Name(s)

Ciprodex Otic Suspension

Other Intervention Name(s)

Ciprodex, Ciprodex b.i.d.

Intervention Description

4 gtt b.i.d. for 7 days.

Intervention Type

Drug

Intervention Name(s)

Ciprodexa Otic Foam

Other Intervention Name(s)

Ciprofloxacin, Dexamethasone Otic Foam, Ciprodexa foam once-a-day

Intervention Description

0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days

Primary Outcome Measure Information:

Title

Clinical cure [lack of need of additional therapy]

Description

Time Frame

Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days

Secondary Outcome Measure Information:

Title

Otalgia/ear pain

Description

Ear pain as reported by the patient

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]

Title

Inflammation/ear edema

Time Frame

At the test-of-cure visit [Day 8 to Day 14]

Title

Ear discharge/otorrhea

Time Frame

At the test-of-cure visit [Day 8 to Day 14]

Title

tenderness with movement of pinna

Time Frame

At the test-of-cure visit [Day 8 - Day 14]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Soroka Medical Center

City

Beer Sheva

Country

Israel

Facility Name

Wolfson Medical Center

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

Facility Name

Clalit Health Services - Raziel Clinic

City

Natania

Country

Israel

Facility Name

Maccabi Healthcare Services (H.M.O.)

City

Tel Aviv

Country

Israel

Facility Name

Sourasky Medical Center (Ichilov)

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

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