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

NCT00872209 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-12-24

No results posted yet for this study

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

Interventions

DRUG

0.3% Ciprofloxacin Ear Drops

4 gtt BID for 7 days.

DRUG

0.3% Ciprofloxacin Foam Otic Cipro

1 application, BID for 7 days

Sponsors & Collaborators

  • Otic Pharma

    lead INDUSTRY

Principal Investigators

  • Yehudah Roth, MD · Edith Wolfson Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872209 on ClinicalTrials.gov