CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
EXE844 Sterile Otic Suspension, 0.3% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02539654
NCT02539654Phase 1Completed
CompareCT.gov

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

Alcon Research·interventional·Posted Sep 3, 2015·Updated Aug 7, 2018

In Brief

A Phase 1 clinical trial evaluating EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion for Otitis Media With Effusion in Children and Otitis Media Recurrent. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media With Effusion in Children, Otitis Media Recurrent
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 3, 2015
Enrollment StartNov 17, 2015
Primary CompletionJun 24, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.8 years ago

Interventions

EXE844 Sterile Otic Suspension, 0.3%drug

Tympanostomy Tube Insertionprocedure