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The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or >2 years.
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-201 | Experimental | OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. |
|
| Sham | Sham Comparator | Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-201 | Drug | Single, intratympanic injection |
| |
| Sham |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Treatment Failures | Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up. | Day 15 - 2 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry | Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations. | Up to one month |
| Microbiological Response |
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Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Carl LeBel, PhD | Otonomy, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call/email Otonomy Central Contact for Trial Locations | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26985629 | Derived | Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001. |
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The reporting group includes all randomized participants (n=266)
Participants were recruited from 29 centers, 25 in the United States and 4 from Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-201 | OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. |
| FG001 | Sham | Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The reporting group includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-201 | OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. |
| BG001 | Sham | Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery. |
| 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 Participants Who Were Treatment Failures | Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up. | Full Analysis Set | Posted | Number | percentage of treatment failures | Day 15 - 2 weeks after dosing |
|
Up to 6 weeks for each subject with total study time of 7 months. All AEs reported or observed after the informed consent had been signed and during or after dosing with the study drug were recorded on the AE page of the eCRF for all randomized subjects.
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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 | OTO-201 Single, Intratympanic Injection | OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Otonomy, Inc | 1-800-826-6411 | medinfo@otonomy.com |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Drug |
Simulated single, intratympanic injection |
|
Subjects whose samples tested positive for bacteria in either or both ears. |
| Day 15 - 2 weeks after dosing |
| Parent changed their mind |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sham |
Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery. |
|
|
| Secondary | Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry | Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations. | Safety Analysis Set (number of ears is equivalent to number of participants) | Posted | Number | percentage of ears | Up to one month |
|
|
|
| Secondary | Microbiological Response | Subjects whose samples tested positive for bacteria in either or both ears. | Microbiologically Evaluable Set | Posted | Number | percentage of Microbiological response | Day 15 - 2 weeks after dosing |
|
|
|
| 3 |
| 179 |
| 64 |
| 179 |
| EG001 | Sham-Simulated Single, Intratympanic Injection | Sham: One sham injection into each ear during surgery. | 0 | 86 | 28 | 86 |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
From the Protocol:
14.11. Use of Information and Publication. All information concerning OTO-201...remains the sole property of Otonomy. Any publication or other public presentation of results from this study requires prior review and written approval of Otonomy. Draft abstracts, manuscripts, and materials for presentation at scientific meetings should be provided to the sponsor at least 30 working days prior to abstract or other relevant submission deadlines.
| Audiometry Patent tubes @ day 29-left ear |
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| Audiometry Patent tubes @ day 29-right ear |
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| Tympanometry Category of B (large) day 29-left ear |
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| Tympanometry Category of B (large)day 29-right ear |
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