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Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

NCT01908803 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-12-06

Study results available
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Summary

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Conditions

  • Acute Otitis Media

Interventions

DRUG

AL-60371/AL-817 otic suspension

DRUG

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

CIPRODEX®

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Manager, GCRA, Pharma · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-08-31
Completion
2014-08-31

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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 NCT01908803 on ClinicalTrials.gov