MedTrace Logo

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

NCT01359098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-11-02

No results posted yet for this study

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

Interventions

DRUG

Ciprodex Otic Suspension

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

DRUG

Ciprodexa Otic Foam

0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, 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
3 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-10-31
Completion
2011-11-30

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 NCT01359098 on ClinicalTrials.gov