Back to resultsSafety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Primary Purpose
Otitis Media With Effusion in Children, Otitis Media Recurrent
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
EXE844 Sterile Otic Suspension, 0.3%
Tympanostomy Tube Insertion
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion in Children
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
EXE844 for 7 Days + Tubes
EXE844 for 3 Days + Tubes
Tubes Only
Arm Description
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Bilateral myringotomy and tympanostomy tube insertion
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02436304
Brief Title
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Official Title
Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 19, 2015 (Actual)
Primary Completion Date
August 4, 2016 (Actual)
Study Completion Date
August 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion in Children, Otitis Media Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXE844 for 7 Days + Tubes
Arm Type
Experimental
Arm Description
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
Arm Title
EXE844 for 3 Days + Tubes
Arm Type
Experimental
Arm Description
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Arm Title
Tubes Only
Arm Type
Active Comparator
Arm Description
Bilateral myringotomy and tympanostomy tube insertion
Intervention Type
Drug
Intervention Name(s)
EXE844 Sterile Otic Suspension, 0.3%
Intervention Type
Procedure
Intervention Name(s)
Tympanostomy Tube Insertion
Intervention Description
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Primary Outcome Measure Information:
Title
Percentage of Subjects With Sustained Clinical Cure at Day 8
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Microbiological Success at Day 14
Description
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
Title
Time to Cessation of Otorrhea
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Ophtha-GCRA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
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