Trial Outcomes & Findings for Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (NCT NCT01535560)
NCT ID: NCT01535560
Last Updated: 2013-12-10
Results Overview
An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.
COMPLETED
PHASE3
589 participants
Day 11
2013-12-10
Participant Flow
Participants were recruited from 53 investigational centers located in the United States, Puerto Rico, and Canada.
Of the 589 participants enrolled, 40 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants.
Participant milestones
| Measure |
AL-60371
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
274
|
275
|
|
Overall Study
COMPLETED
|
237
|
179
|
|
Overall Study
NOT COMPLETED
|
37
|
96
|
Reasons for withdrawal
| Measure |
AL-60371
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Subj Decision Unrel to an Adverse Event
|
3
|
1
|
|
Overall Study
Treatment Failure
|
21
|
83
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Randomized in Error
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Baseline characteristics by cohort
| Measure |
AL-60371
n=274 Participants
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
n=274 Participants
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
Total
n=548 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Infants and Toddlers (28 days to 23 months)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Children (2 to 11 years)
|
130 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12 to 17 years)
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Customized
Adults (18 to 64 years)
|
80 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Age, Customized
Elderly (≥ 65 years)
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.
An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.
Outcome measures
| Measure |
AL-60371
n=147 Participants
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
n=130 Participants
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
|
68.7 Percentage of participants
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 11Population: This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.
Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.
Outcome measures
| Measure |
AL-60371
n=147 Participants
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
n=130 Participants
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
|
66.0 Percentage of participants
|
11.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Time to event (Day 1 to Day 11)Population: This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.
Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.
Outcome measures
| Measure |
AL-60371
n=138 Participants
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
|
Vehicle
n=125 Participants
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary
|
3.0 Days
Standard Error 0.2
|
6.5 Days
Standard Error 0.3
|
Adverse Events
AL-60371
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sally Schieb, Sr. Clinical Project Lead
Alcon Research, Ltd.
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