Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 433 for:    OTITIS

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432105
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : July 12, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Otitis Media With Effusion in Children
Otitis Media Recurrent
Interventions Drug: EXE844 Sterile Otic Suspension, 0.3%
Procedure: Tympanostomy Tube Insertion
Enrollment 470
Recruitment Details Participants were recruited from 18 study centers located in the US and 2 study centers located in Canada.
Pre-assignment Details Of the 470 enrolled, 85 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (385).
Arm/Group Title EXE844 7 Days EXE844 3 Days Tubes Only
Hide Arm/Group Description EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion Bilateral myringotomy and tympanostomy tube insertion
Period Title: Overall Study
Started 164 110 111
Completed 162 108 108
Not Completed 2 2 3
Reason Not Completed
Lost to Follow-up             1             1             0
Withdrawal by Subject             1             0             1
Culture positive for yeast             0             1             0
Randomized in error             0             0             2
Arm/Group Title EXE844 7 Days EXE844 3 Days Tubes Only Total
Hide Arm/Group Description EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion Bilateral myringotomy and tympanostomy tube insertion Total of all reporting groups
Overall Number of Baseline Participants 164 110 111 385
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects, including those who underwent concurrent adenoidectomy and/or tonsillectomy (Intent-to-treat (ITT) analysis set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 110 participants 111 participants 385 participants
2.2  (1.82) 2.1  (1.59) 2.2  (1.92) 2.2  (1.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 110 participants 111 participants 385 participants
Female
56
  34.1%
45
  40.9%
46
  41.4%
147
  38.2%
Male
108
  65.9%
65
  59.1%
65
  58.6%
238
  61.8%
1.Primary Outcome
Title Percentage of Subjects With Sustained Clinical Cure at Day 8
Hide Description A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EXE844 7 Days EXE844 3 Days Tubes Only
Hide Arm/Group Description:
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Bilateral myringotomy and tympanostomy tube insertion
Overall Number of Participants Analyzed 164 110 111
Measure Type: Number
Unit of Measure: percentage of participants
76.2 71.8 56.8
2.Secondary Outcome
Title Percentage of Subjects With Microbiological Success at Day 14
Hide Description Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all ITT subjects who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set).
Arm/Group Title EXE844 7 Days EXE844 3 Days Tubes Only
Hide Arm/Group Description:
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Bilateral myringotomy and tympanostomy tube insertion
Overall Number of Participants Analyzed 96 60 62
Measure Type: Number
Unit of Measure: percentage of participants
74.0 60.0 50.0
3.Secondary Outcome
Title Time to Cessation of Otorrhea
Hide Description Time (in days) to the 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 via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EXE844 7 Days EXE844 3 Days Tubes Only
Hide Arm/Group Description:
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Bilateral myringotomy and tympanostomy tube insertion
Overall Number of Participants Analyzed 164 110 111
Median (95% Confidence Interval)
Unit of Measure: days
2.5
(1.5 to 3.5)
1.5
(1.0 to 2.5)
8.0
(2.5 to 13.0)
Time Frame Adverse events (AEs) were collected for the duration of a subject’s participation in the study (up to 19 days).This analysis population includes all participants who had tympanostomy tubes inserted and were randomized. AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title Pretreatment EXE844 7 Days EXE844 3 Days Tubes Only
Hide Arm/Group Description All AEs reported prior to randomization All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 3 days after Tympanostomy Tube Insertion All participants treated with bilateral myringotomy and tympanostomy tube insertion only
All-Cause Mortality
Pretreatment EXE844 7 Days EXE844 3 Days Tubes Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/470 (0.00%)   0/164 (0.00%)   0/110 (0.00%)   0/111 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pretreatment EXE844 7 Days EXE844 3 Days Tubes Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/470 (0.21%)   1/164 (0.61%)   1/110 (0.91%)   0/111 (0.00%) 
Gastrointestinal disorders         
Intussusception  1  0/470 (0.00%)  0/164 (0.00%)  1/110 (0.91%)  0/111 (0.00%) 
Infections and infestations         
Viral rash  1  0/470 (0.00%)  1/164 (0.61%)  0/110 (0.00%)  0/111 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/470 (0.21%)  0/164 (0.00%)  0/110 (0.00%)  0/111 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment EXE844 7 Days EXE844 3 Days Tubes Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/470 (1.49%)   27/164 (16.46%)   21/110 (19.09%)   40/111 (36.04%) 
Ear and labyrinth disorders         
Otorrhoea  1  0/470 (0.00%)  6/164 (3.66%)  6/110 (5.45%)  16/111 (14.41%) 
Ear pain  1  1/470 (0.21%)  2/164 (1.22%)  5/110 (4.55%)  6/111 (5.41%) 
Gastrointestinal disorders         
Vomiting  1  1/470 (0.21%)  2/164 (1.22%)  2/110 (1.82%)  7/111 (6.31%) 
General disorders         
Pyrexia  1  1/470 (0.21%)  16/164 (9.76%)  9/110 (8.18%)  14/111 (12.61%) 
Infections and infestations         
Upper respiratory tract infection  1  5/470 (1.06%)  5/164 (3.05%)  6/110 (5.45%)  8/111 (7.21%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
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: Clinical Scientific Director, GCRA - Global Clinical Development
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02432105     History of Changes
Other Study ID Numbers: EXE844b-C001
First Submitted: April 28, 2015
First Posted: May 1, 2015
Results First Submitted: June 15, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 2, 2018