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Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

NCT02436304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2018-07-02

Study results available
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Summary

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Conditions

  • Otitis Media With Effusion in Children
  • Otitis Media Recurrent

Interventions

DRUG

EXE844 Sterile Otic Suspension, 0.3%

PROCEDURE

Tympanostomy Tube Insertion

Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Manager, Ophtha-GCRA · Alcon, A Novartis Division

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
2015-06-19
Primary Completion
2016-08-04
Completion
2016-08-04

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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 NCT02436304 on ClinicalTrials.gov