Trial Outcomes & Findings for Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2 (NCT NCT02436304)
NCT ID: NCT02436304
Last Updated: 2018-07-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
Day 8
Results posted on
2018-07-02
Participant Flow
Participants were recruited from 19 study centers located in Canada (3) and the US (16).
Of the 404 enrolled, 48 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (356).
Participant milestones
| Measure |
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
|
EXE844 3 Days
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
Bilateral myringotomy and tympanostomy tube insertion
|
|---|---|---|---|
|
Overall Study
STARTED
|
153
|
102
|
101
|
|
Overall Study
COMPLETED
|
153
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
EXE844 3 Days
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
Bilateral myringotomy and tympanostomy tube insertion
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Randomized in error didn't meet I/E crit
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Baseline characteristics by cohort
| Measure |
EXE844 7 Days
n=153 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
|
EXE844 3 Days
n=102 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
n=101 Participants
Bilateral myringotomy and tympanostomy tube insertion
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
2.3 years
STANDARD_DEVIATION 2.05 • n=5 Participants
|
2.8 years
STANDARD_DEVIATION 2.31 • n=7 Participants
|
2.6 years
STANDARD_DEVIATION 2.31 • n=5 Participants
|
2.5 years
STANDARD_DEVIATION 2.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: ITT analysis set
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).
Outcome measures
| Measure |
EXE844 7 Days
n=153 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
|
EXE844 3 Days
n=102 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
n=101 Participants
Bilateral myringotomy and tympanostomy tube insertion
|
|---|---|---|---|
|
Percentage of Subjects With Sustained Clinical Cure at Day 8
|
77.1 percentage of participants
|
75.5 percentage of participants
|
65.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 14Population: 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)
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).
Outcome measures
| Measure |
EXE844 7 Days
n=80 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
|
EXE844 3 Days
n=58 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
n=52 Participants
Bilateral myringotomy and tympanostomy tube insertion
|
|---|---|---|---|
|
Percentage of Subjects With Microbiological Success at Day 14
|
72.5 percentage of participants
|
69.0 percentage of participants
|
51.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: ITT analysis set
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).
Outcome measures
| Measure |
EXE844 7 Days
n=153 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
|
EXE844 3 Days
n=102 Participants
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
n=101 Participants
Bilateral myringotomy and tympanostomy tube insertion
|
|---|---|---|---|
|
Time to Cessation of Otorrhea
|
2.5 days
Interval 1.5 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
1.5 days
Interval 0.5 to 3.5
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EXE844 7 Days
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
EXE844 3 Days
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Tubes Only
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pretreatment
n=404 participants at risk
All who consented to participate in the study prior to randomization
|
EXE844 7 Days
n=153 participants at risk
All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
|
EXE844 3 Days
n=102 participants at risk
All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion
|
Tubes Only
n=101 participants at risk
All participants who underwent bilateral myringotomy and tympanostomy tube insertion only
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/404 • 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.
|
7.2%
11/153 • 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.
|
4.9%
5/102 • 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.
|
5.0%
5/101 • 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.
|
|
General disorders
Pyrexia
|
0.25%
1/404 • 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.
|
7.8%
12/153 • 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.
|
5.9%
6/102 • 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.
|
3.0%
3/101 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.25%
1/404 • 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.
|
6.5%
10/153 • 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.
|
2.9%
3/102 • 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.
|
3.0%
3/101 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/404 • 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.
|
4.6%
7/153 • 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.
|
5.9%
6/102 • 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.
|
4.0%
4/101 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/404 • 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.
|
6.5%
10/153 • 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.
|
2.0%
2/102 • 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.
|
4.0%
4/101 • 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.
|
Additional Information
Clinical Scientific Director, GCRA
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER