Trials / Completed
CompletedNCT02539654
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EXE844 Sterile Otic Suspension, 0.3% | |
| PROCEDURE | Tympanostomy Tube Insertion |
Timeline
- Start date
- 2015-11-17
- Primary completion
- 2016-06-24
- Completion
- 2016-06-24
- First posted
- 2015-09-03
- Last updated
- 2018-08-07
- Results posted
- 2018-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02539654. Inclusion in this directory is not an endorsement.