drugset / Trial / NCT02539654

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

NCT02539654 ↗

Phase 1 Completed 14 enrolled Alcon Research
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2015-11-17
Primary completion
2016-06-24
Completion
2016-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject EXE844 Unknown 0.3 % Other