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

Sponsor

Otic Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01359098

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis	Drug: Ciprodex Otic Suspension Drug: Ciprodexa Otic Foam	Phase 2

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ciprodex Otic Suspension Ciprodex Sterile Otic Solution (Alcon, Inc.)	Drug: Ciprodex Otic Suspension 4 gtt b.i.d. for 7 days. Other Names: Ciprodex Ciprodex b.i.d.
Experimental: Ciprodexa Otic Foam Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)	Drug: Ciprodexa Otic Foam 0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days Other Names: Ciprofloxacin, Dexamethasone Otic Foam Ciprodexa foam once-a-day

Arm

Intervention/Treatment

Active Comparator: Ciprodex Otic Suspension

Ciprodex Sterile Otic Solution (Alcon, Inc.)

Drug: Ciprodex Otic Suspension

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

Other Names:

Ciprodex

Ciprodex b.i.d.

Experimental: Ciprodexa Otic Foam

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

Drug: Ciprodexa Otic Foam

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

Other Names:

Ciprofloxacin, Dexamethasone Otic Foam

Ciprodexa foam once-a-day

Outcome Measures

Primary Outcome Measures

Clinical cure [lack of need of additional therapy] [Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days]
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 [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]]
Ear pain as reported by the patient
Inflammation/ear edema [At the test-of-cure visit [Day 8 to Day 14]]
Ear discharge/otorrhea [At the test-of-cure visit [Day 8 to Day 14]]
tenderness with movement of pinna [At the test-of-cure visit [Day 8 - Day 14]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	HaEmek Medical Center	Afula	Israel
2	Soroka Medical Center	Beer Sheva	Israel
3	Wolfson Medical Center	Holon	Israel	58100
4	Meir Medical Center	Kfar Saba	Israel
5	Clalit Health Services - Raziel Clinic	Natania	Israel
6	Maccabi Healthcare Services (H.M.O.)	Tel Aviv	Israel
7	Sourasky Medical Center (Ichilov)	Tel Aviv	Israel