Trial Outcomes & Findings for Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa (NCT NCT03196973)
NCT ID: NCT03196973
Last Updated: 2021-04-09
Results Overview
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
End of Treatment (Day 8+2)
Results posted on
2021-04-09
Participant Flow
Participant milestones
| Measure |
DF289 Plus DF277
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
197
|
196
|
100
|
|
Overall Study
COMPLETED
|
188
|
184
|
95
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
5
|
Reasons for withdrawal
| Measure |
DF289 Plus DF277
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
2
|
|
Overall Study
Consent withdrawn
|
2
|
1
|
0
|
|
Overall Study
Administration of a wrong kit of study medication
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Baseline characteristics by cohort
| Measure |
DF289 Plus DF277
n=197 Participants
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
n=196 Participants
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
n=100 Participants
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
Total
n=493 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 23.81 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 22.64 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 22.79 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 23.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
197 participants
n=5 Participants
|
196 participants
n=7 Participants
|
100 participants
n=5 Participants
|
493 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (Day 8+2)Population: Randomized patients with positive culture for pathogens at baseline
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Outcome measures
| Measure |
DF289 Plus DF277
n=103 Participants
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
n=91 Participants
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
n=45 Participants
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Therapeutic Cure (Clinical + Microbiological Cure)
|
63 Participants
|
49 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From baseline to End of Study (Day 15+2)Population: Randomized patients with positive culture for pathogens at baseline
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Outcome measures
| Measure |
DF289 Plus DF277
n=103 Participants
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
n=91 Participants
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
n=45 Participants
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Time to End of Pain
|
5.0 days
Interval 4.23 to 6.34
|
5.9 days
Interval 4.26 to 7.25
|
7.7 days
Interval 6.74 to 9.0
|
Adverse Events
DF289 Plus DF277
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
DF289
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DF277
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DF289 Plus DF277
n=196 participants at risk
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
n=195 participants at risk
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
n=100 participants at risk
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Psychiatric disorders
Acute Psychosis
|
0.51%
1/196 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/195 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
Other adverse events
| Measure |
DF289 Plus DF277
n=196 participants at risk
Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days
|
DF289
n=195 participants at risk
Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days
|
DF277
n=100 participants at risk
Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days
|
|---|---|---|---|
|
Cardiac disorders
tachycardia
|
0.51%
1/196 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/195 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
1/100 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Ear and labyrinth disorders
ear pain
|
1.0%
2/196 • Number of events 2 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
2/195 • Number of events 2 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Ear and labyrinth disorders
ear pruritus
|
0.00%
0/196 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
2/195 • Number of events 2 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
General disorders
application site pain
|
2.0%
4/196 • Number of events 4 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/195 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Infections and infestations
cellulitis
|
0.00%
0/196 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/195 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
1/100 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Infections and infestations
otitis media
|
0.00%
0/196 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/195 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
1/100 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/196 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
2/195 • Number of events 2 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Nervous system disorders
headache
|
2.0%
4/196 • Number of events 4 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
3.1%
6/195 • Number of events 6 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
1/100 • Number of events 1 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
|
Nervous system disorders
dizziness
|
0.00%
0/196 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
1.0%
2/195 • Number of events 2 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
0.00%
0/100 • From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms. 2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication by PI of the Study Results shall not be made before the first multi-center publication. PI shall allow Sponsor not less than 60 days to review any manuscript and not less than 30 days to review any other documentation which describes or discloses the Study Results. Sponsor can request an additional 60 days. Sponsor reserves the right to remove all Confidential Information from any publications or presentations.
- Publication restrictions are in place
Restriction type: OTHER