A Phase 3 interventional study of EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion in Otitis Media With Effusion in Children and Otitis Media Recurrent, sponsored by Alcon Research. Completed. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2018-07-02.
Sponsored by Alcon Research · Phase 3, Interventional, and Treatment
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).
246 studies on the registry are indexed under Otitis; 21 are open to participants now.
This study's enrollment of 404 is above the median of 126 across 173 interventional studies indexed under Otitis.
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Exclusion Criteria:
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
Drug: EXE844 Sterile Otic Suspension, 0.3% · Procedure: Tympanostomy Tube Insertion
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Drug: EXE844 Sterile Otic Suspension, 0.3% · Procedure: Tympanostomy Tube Insertion
Bilateral myringotomy and tympanostomy tube insertion
Procedure: Tympanostomy Tube Insertion
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Percentage of Subjects With Sustained Clinical Cure at Day 8
Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time frame: Day 8
Percentage of Subjects With Microbiological Success at Day 14
Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time frame: Day 14
Time to Cessation of Otorrhea
The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time frame: Up to Day 14
Participants were recruited from 19 study centers located in Canada (3) and the US (16).
| Milestone | EXE844 7 Days | EXE844 3 Days | Tubes Only |
|---|---|---|---|
| Started | 153 | 102 | 101 |
| Completed | 153 | 100 | 100 |
| Not completed | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Randomized in error didn't meet i/e crit | 0 | 0 | 1 |
Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
| percentage of participants | EXE844 7 Days | EXE844 3 Days | Tubes Only |
|---|---|---|---|
| Percentage of Subjects With Sustained Clinical Cure at Day 8 | 77.1 | 75.5 | 65.3 |
Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
| percentage of participants | EXE844 7 Days | EXE844 3 Days | Tubes Only |
|---|---|---|---|
| Percentage of Subjects With Microbiological Success at Day 14 | 72.5 | 69.0 | 51.9 |
The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
| days | EXE844 7 Days | EXE844 3 Days | Tubes Only |
|---|---|---|---|
| Time to Cessation of Otorrhea | 2.5 (1.5 to 3.0) | 2.0 (1.0 to 3.0) | 1.5 (0.5 to 3.5) |
Collected over Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 28 days). AEs are reported as pretreatment and treatment-emergent.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/404 (0%) | 0/404 (0%) | 2/404 (0.5%) |
| EXE844 7 Days | 0/153 (0%) | 0/153 (0%) | 39/153 (25.5%) |
| EXE844 3 Days | 0/102 (0%) | 0/102 (0%) | 19/102 (18.6%) |
| Tubes Only | 0/101 (0%) | 0/101 (0%) | 13/101 (12.9%) |
| Event | Pretreatment | EXE844 7 Days | EXE844 3 Days | Tubes Only |
|---|---|---|---|---|
| PyrexiaGeneral disorders | 1/404 | 12/153 | 6/102 | 3/101 |
| Ear PainEar and labyrinth disorders | 0/404 | 11/153 | 5/102 | 5/101 |
| Upper respiratory tract infectionInfections and infestations | 1/404 | 10/153 | 3/102 | 3/101 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/404 | 10/153 | 2/102 | 4/101 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/404 | 7/153 | 6/102 | 4/101 |
This analysis population includes all randomized participants, including those who underwent concurrent adenoidectomy and/or tonsillectomy (Intent-to-treat (ITT) analysis set)
| Age, Continuous(years) | EXE844 7 Days | EXE844 3 Days | Tubes Only | Total |
|---|---|---|---|---|
| Mean | 2.3 ± 2.05 | 2.8 ± 2.31 | 2.6 ± 2.31 | 2.5 ± 2.20 |
| Sex: Female, Male(Participants) | EXE844 7 Days | EXE844 3 Days | Tubes Only | Total |
|---|---|---|---|---|
| Female | 53 | 43 | 40 | 136 |
| Male | 100 | 59 | 61 | 220 |
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