Trials / Completed
CompletedNCT02436304
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 404 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EXE844 Sterile Otic Suspension, 0.3% | |
| PROCEDURE | Tympanostomy Tube Insertion | Surgical procedure for treating pediatric cases of recurrent or chronic otitis media |
Timeline
- Start date
- 2015-06-19
- Primary completion
- 2016-08-04
- Completion
- 2016-08-04
- First posted
- 2015-05-06
- Last updated
- 2018-07-02
- Results posted
- 2017-08-28
Source: ClinicalTrials.gov record NCT02436304. Inclusion in this directory is not an endorsement.