Trial Outcomes & Findings for Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (NCT NCT01535599)
NCT ID: NCT01535599
Last Updated: 2014-07-08
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. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
COMPLETED
PHASE3
768 participants
Day 11
2014-07-08
Participant Flow
Participants were recruited from 68 investigational centers located in the United States, Puerto Rico, and Canada.
Of the 768 consented participants, 75 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (693).
Participant milestones
| Measure |
AL-60371
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
347
|
346
|
|
Overall Study
COMPLETED
|
297
|
250
|
|
Overall Study
NOT COMPLETED
|
50
|
96
|
Reasons for withdrawal
| Measure |
AL-60371
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Subj Decision Unrelated to Adverse Event
|
4
|
3
|
|
Overall Study
Treatment Failure
|
33
|
66
|
|
Overall Study
BL Culture + for Group A Strep
|
0
|
1
|
|
Overall Study
BL Culture + for Yeast//Fungi
|
0
|
1
|
|
Overall Study
Randomized in Error
|
2
|
4
|
|
Overall Study
Did not use product
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Stopped medication
|
0
|
1
|
|
Overall Study
Noncompliance
|
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=344 Participants
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
n=342 Participants
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
Total
n=686 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Infants/Toddlers (18 days to 23 months)
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
Children (2 to 11 years)
|
61 participants
n=99 Participants
|
83 participants
n=107 Participants
|
144 participants
n=206 Participants
|
|
Age, Customized
Adolescents (12 to 17 years)
|
64 participants
n=99 Participants
|
42 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Age, Customized
Adults (18 to 64 years)
|
195 participants
n=99 Participants
|
186 participants
n=107 Participants
|
381 participants
n=206 Participants
|
|
Age, Customized
Elderly (≥ 65 years)
|
21 participants
n=99 Participants
|
29 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
385 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
301 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication 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. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
Outcome measures
| Measure |
AL-60371
n=145 Participants
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
n=138 Participants
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
|
71.7 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 11Population: This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.
Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
Outcome measures
| Measure |
AL-60371
n=145 Participants
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
n=138 Participants
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
|
66.9 percentage of participants
|
13.0 percentage of participants
|
SECONDARY outcome
Timeframe: Time to event, up to Day 11Population: This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis.
Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.
Outcome measures
| Measure |
AL-60371
n=138 Participants
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
n=128 Participants
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
|
4.0 days
Standard Error 0.2
|
7.0 days
Standard Error 0.4
|
Adverse Events
AL-60371
Vehicle
Serious adverse events
| Measure |
AL-60371
n=344 participants at risk
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
|
Vehicle
n=342 participants at risk
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/344 • Adverse events (AE) were collected for the duration of the study (1 year, 2 months). An AE was considered to be any untoward medical occurrence in a participant who was exposed to the study medication, regardless of causal relationship.
This reporting group includes all randomized participants who were treated with study medication (686). AEs were obtained as solicited comments from the study participants and as observations by the study Investigator.
|
0.29%
1/342 • Adverse events (AE) were collected for the duration of the study (1 year, 2 months). An AE was considered to be any untoward medical occurrence in a participant who was exposed to the study medication, regardless of causal relationship.
This reporting group includes all randomized participants who were treated with study medication (686). AEs were obtained as solicited comments from the study participants and as observations by the study Investigator.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/344 • Adverse events (AE) were collected for the duration of the study (1 year, 2 months). An AE was considered to be any untoward medical occurrence in a participant who was exposed to the study medication, regardless of causal relationship.
This reporting group includes all randomized participants who were treated with study medication (686). AEs were obtained as solicited comments from the study participants and as observations by the study Investigator.
|
0.29%
1/342 • Adverse events (AE) were collected for the duration of the study (1 year, 2 months). An AE was considered to be any untoward medical occurrence in a participant who was exposed to the study medication, regardless of causal relationship.
This reporting group includes all randomized participants who were treated with study medication (686). AEs were obtained as solicited comments from the study participants and as observations by the study Investigator.
|
Other adverse events
Adverse event data not reported
Additional Information
Sally Scheib, 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