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Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

Otitis Media With Effusion in Children Clinical Trial

Official title:
An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

Clinical Trial Summary

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02539654
Study type Interventional
Source Alcon Research
Contact
Status Completed
Phase Phase 1
Start date November 17, 2015
Completion date June 24, 2016
View Details
See also
  Status Clinical Trial Phase
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Withdrawn NCT03347461 - Otiprio Versus Ciprodex Tympanostomy Tube Outcomes Phase 4
Completed NCT02432105 - Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) Phase 3
Completed NCT02436304 - Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2 Phase 3
Completed NCT06100159 - Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion N/A