Phase 3
N=356
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Otitis Media With Effusion in Children · Otitis Media Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT02436304 ↗Enrolled (actual)
356
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 77.1; 75.5; 65.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EXE844 Sterile Otic Suspension, 0.3% (Drug); Tympanostomy Tube Insertion (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Sustained Clinical Cure at Day 8 |
77.1; 75.5; 65.3 | — |
| SECONDARY Percentage of Subjects With Microbiological Success at Day 14 |
72.5; 69.0; 51.9 | — |
| SECONDARY Time to Cessation of Otorrhea |
2.5; 2.0; 1.5 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
- Suspected bacterial infection at time of surgery in at least 1 ear.
- Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
- Legally Authorized Representative (LAR) must read and sign the informed consent.
- Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
- Middle ear pathology in either ear other than otitis media.
- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
- Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
- Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02436304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.