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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXE844 for 7 Days + Tubes | Experimental | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion |
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| EXE844 for 3 Days + Tubes | Experimental | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
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| Tubes Only | Active Comparator | Bilateral myringotomy and tympanostomy tube insertion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXE844 Sterile Otic Suspension, 0.3% | Drug |
| ||
| Tympanostomy Tube Insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Ophtha-GCRA | Alcon, A Novartis Division | Study Director |
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Of the 404 enrolled, 48 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (356).
Participants were recruited from 19 study centers located in Canada (3) and the US (16).
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| ID | Title | Description |
|---|---|---|
| FG000 | EXE844 7 Days | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion |
| FG001 | EXE844 3 Days | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Procedure |
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media |
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| 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). | Up to Day 14 |
| FG002 | Tubes Only | Bilateral myringotomy and tympanostomy tube insertion |
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| NOT COMPLETED |
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This analysis population includes all randomized participants, including those who underwent concurrent adenoidectomy and/or tonsillectomy (Intent-to-treat (ITT) analysis set)
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| ID | Title | Description |
|---|---|---|
| BG000 | EXE844 7 Days | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion |
| BG001 | EXE844 3 Days | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
| BG002 | Tubes Only | Bilateral myringotomy and tympanostomy tube insertion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | ITT analysis set | Posted | Number | percentage of participants | Day 8 |
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| Secondary | 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). | This analysis population includes all ITT participants who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set) | Posted | Number | percentage of participants | Day 14 |
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| Secondary | 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). | ITT analysis set | Posted | Median | 95% Confidence Interval | days | Up to Day 14 |
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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.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study participants and as observations by the Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | All who consented to participate in the study prior to randomization | 0 | 404 | 0 | 404 | 2 | 404 |
| EG001 | EXE844 7 Days | All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion | 0 | 153 | 0 | 153 | 39 | 153 |
| EG002 | EXE844 3 Days | All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion | 0 | 102 | 0 | 102 | 19 | 102 |
| EG003 | Tubes Only | All participants who underwent bilateral myringotomy and tympanostomy tube insertion only | 0 | 101 | 0 | 101 | 13 | 101 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientific Director, GCRA | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D008876 | Middle Ear Ventilation |
| ID | Term |
|---|---|
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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| Male |
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| Units | Counts |
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| Participants |
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