Trials / Completed
CompletedNCT02432105
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
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
- 470 (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
- 2015-06-25
- Primary completion
- 2016-06-15
- Completion
- 2016-06-15
- First posted
- 2015-05-01
- Last updated
- 2018-07-02
- Results posted
- 2017-07-12
Source: ClinicalTrials.gov record NCT02432105. Inclusion in this directory is not an endorsement.