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Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa

NCT02216071 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2021-05-28

Study results available
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Summary

The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Conditions

  • Acute Otitis Externa

Interventions

DRUG

Ciprodex®

Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

DRUG

EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension

Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

Sponsors & Collaborators

  • Exela Pharma Sciences, LLC.

    lead INDUSTRY

Principal Investigators

  • Michael H Silverman, MD · BioStrategics Consulting Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-20
Primary Completion
2015-08-11
Completion
2015-08-11

Countries

  • United States
  • Puerto Rico

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 NCT02216071 on ClinicalTrials.gov