Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa

NCT00872209 | Completed Phase 1 DMC

• 1 other identifier: OP-001-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

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 (BID, for 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: 0.3% Ciprofloxacin Foam Otic Cipro

Interventions

0.3% Ciprofloxacin Ear Drops DRUG

4 gtt BID for 7 days.

Also known as: Ciloxan, Ciprofloxacin, Cipro

Ciloxan Ear Drops

0.3% Ciprofloxacin Foam Otic Cipro DRUG

1 application, BID for 7 days

Also known as: Ciloxan, 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 (4)

HaEmek Medical Center

Afula, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Maccabi Healthcare Services

Tel Aviv, 68125, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, 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 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 29, 2009
• First Posted: March 31, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

IL (4)