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

NCT01157819 | Completed Phase 2 DMC

• 1 other identifier: OP-002-000
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

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 confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion

  within 7 days after completion of treatment that lasts 7 days

Study Arms (2)

Ciloxan Ear Drops

ACTIVE COMPARATOR

Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops

Drug: 0.3% Ciprofloxacin Ear Drops

Foam Otic Cipro

EXPERIMENTAL

Patients randomized to this study arm will receive the experimental product

Drug: FoamOtic Cipro

Interventions

0.3% Ciprofloxacin Ear Drops DRUG

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

Also known as: Ciloxan, Ciprofloxacin, Cipro

Ciloxan Ear Drops

FoamOtic Cipro DRUG

0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days

Also known as: Ciprofloxacin, Cipro

Foam Otic Cipro

Eligibility Criteria

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

You may qualify if:

• 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

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.
• 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.

Sponsors & Collaborators

• Otic Pharma: lead

Study Sites (2)

Wolfson Medical Center

Holon, 58100, Israel

Location

Bet Roter Clinic, Clalit Health Services

Holon, 58320, 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

Study Record Dates

• First Submitted: July 4, 2010
• First Posted: July 7, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

IL (2)