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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 |
|
| 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 |
|
| Tubes Only | Active Comparator | Bilateral myringotomy and tympanostomy tube insertion |
|
| 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 | A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with 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) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with 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 Research | Study Director |
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Of the 470 enrolled, 85 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (385).
Participants were recruited from 18 study centers located in the US and 2 study centers located in Canada.
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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 |
| FG002 | Tubes Only | Bilateral myringotomy and tympanostomy tube insertion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all randomized subjects, 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | ITT analysis set | Posted | Number | percentage of participants | Day 8 |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 19 days).This analysis population includes all participants who had tympanostomy tubes inserted and were randomized. AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through 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 AEs reported prior to randomization | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otorrhoea | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientific Director, GCRA - Global Clinical Development | 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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| Procedure |
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media |
|
| Day 14 |
| Time to Cessation of Otorrhea | Time (in days) to the 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 via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | Up to Day 14 |
| Culture positive for yeast |
|
| Randomized in error |
|
| BG002 | Tubes Only | Bilateral myringotomy and tympanostomy tube insertion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| EXE844 3 Days |
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
| OG002 | Tubes Only | Bilateral myringotomy and tympanostomy tube insertion |
|
|
| 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) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | This analysis population includes all ITT subjects 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 |
|
|
|
| Secondary | Time to Cessation of Otorrhea | Time (in days) to the 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 via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with 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 |
|
|
|
| 470 |
| 1 |
| 470 |
| 7 |
| 470 |
| EG001 | EXE844 7 Days | All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion | 0 | 164 | 1 | 164 | 27 | 164 |
| EG002 | EXE844 3 Days | All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 3 days after Tympanostomy Tube Insertion | 0 | 110 | 1 | 110 | 21 | 110 |
| EG003 | Tubes Only | All participants treated with bilateral myringotomy and tympanostomy tube insertion only | 0 | 111 | 0 | 111 | 40 | 111 |
| Viral rash | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.