MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-03-15

No results posted yet for this study

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

Interventions

DRUG

0.3% Ciprofloxacin Ear Drops

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

DRUG

FoamOtic Cipro

0.3% Ciprofloxacin Otic Foam, 1 application, q.d. 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
2010-07-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01157819 on ClinicalTrials.gov