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Trial record 35 of 433 for:    OTITIS

Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

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ClinicalTrials.gov Identifier: NCT01535599
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : June 18, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acute Otitis Externa
Interventions Drug: AL-60371, 0.3% Otic Suspension
Other: AL-60371 Vehicle
Enrollment 768
Recruitment Details Participants were recruited from 68 investigational centers located in the United States, Puerto Rico, and Canada.
Pre-assignment Details 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).
Arm/Group Title AL-60371 Vehicle
Hide Arm/Group Description AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Period Title: Overall Study
Started 347 346
Completed 297 250
Not Completed 50 96
Reason Not Completed
Adverse Event             6             15
Lost to Follow-up             3             4
Subj Decision Unrelated to Adverse Event             4             3
Treatment Failure             33             66
BL Culture + for Group A Strep             0             1
BL Culture + for Yeast//Fungi             0             1
Randomized in Error             2             4
Did not use product             1             0
Other             1             0
Stopped medication             0             1
Noncompliance             0             1
Arm/Group Title AL-60371 Vehicle Total
Hide Arm/Group Description AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 344 342 686
Hide Baseline Analysis Population Description
This reporting group includes all randomized participants who were treated with study medication (686). Note: 6 participants were randomized in error and did not receive study medication (3 in AL-60371 and 3 in Vehicle). Additionally 1 participant randomized to Vehicle exited the study at Visit 2 without dosing the study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 342 participants 686 participants
Infants/Toddlers (18 days to 23 months) 3 2 5
Children (2 to 11 years) 61 83 144
Adolescents (12 to 17 years) 64 42 106
Adults (18 to 64 years) 195 186 381
Elderly (≥ 65 years) 21 29 50
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 342 participants 686 participants
Female
202
  58.7%
183
  53.5%
385
  56.1%
Male
142
  41.3%
159
  46.5%
301
  43.9%
1.Primary Outcome
Title Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
Hide Description 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.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AL-60371 Vehicle
Hide Arm/Group Description:
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Overall Number of Participants Analyzed 145 138
Measure Type: Number
Unit of Measure: percentage of participants
71.7 33.3
2.Secondary Outcome
Title Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
Hide Description 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.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AL-60371 Vehicle
Hide Arm/Group Description:
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Overall Number of Participants Analyzed 145 138
Measure Type: Number
Unit of Measure: percentage of participants
66.9 13.0
3.Secondary Outcome
Title Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
Hide Description 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.
Time Frame Time to event, up to Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AL-60371 Vehicle
Hide Arm/Group Description:
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Overall Number of Participants Analyzed 138 128
Median (Standard Error)
Unit of Measure: days
4.0  (0.2) 7.0  (0.4)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title AL-60371 Vehicle
Hide Arm/Group Description AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
All-Cause Mortality
AL-60371 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AL-60371 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/344 (0.00%)   1/342 (0.29%) 
Infections and infestations     
Gastroenteritis * 1  0/344 (0.00%)  1/342 (0.29%) 
Psychiatric disorders     
Anxiety * 1  0/344 (0.00%)  1/342 (0.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AL-60371 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/344 (0.00%)   0/342 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sally Scheib, Sr. Clinical Project Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01535599     History of Changes
Other Study ID Numbers: C-10-018
First Submitted: February 15, 2012
First Posted: February 20, 2012
Results First Submitted: May 19, 2014
Results First Posted: June 18, 2014
Last Update Posted: July 8, 2014