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

NCT01359098 | Completed Phase 2

• 1 other identifier: OP-003-000
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Keywords

swimmer's ear; ear drops; ear foam; otic foam; ear infection; ear pain; ear inflammation

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• 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]

• 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]

Study Arms (2)

Ciprodex Otic Suspension

ACTIVE COMPARATOR

Ciprodex Sterile Otic Solution (Alcon, Inc.)

Drug: Ciprodex Otic Suspension

Ciprodexa Otic Foam

EXPERIMENTAL

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

Drug: Ciprodexa Otic Foam

Interventions

Ciprodex Otic Suspension DRUG

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

Also known as: Ciprodex, Ciprodex b.i.d.

Ciprodex Otic Suspension

Ciprodexa Otic Foam DRUG

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

Also known as: Ciprofloxacin, Dexamethasone Otic Foam, Ciprodexa foam once-a-day

Ciprodexa Otic Foam

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Otic Pharma: lead

Study Sites (7)

Meir Medical Center

Kfar Saba, Israel, Israel

Location

HaEmek Medical Center

Afula, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Clalit Health Services - Raziel Clinic

Netanya, Israel

Location

Maccabi Healthcare Services (H.M.O.)

Tel Aviv, Israel

Location

Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Earache

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yehudah Roth, MD

  Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

IL (7)