Clinical Trial Results:
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Peri-Operative Tube Otorrhea
Summary
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EudraCT number |
2018-000642-19 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
11 Feb 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jul 2018
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First version publication date |
30 Jul 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C-05-38
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00578773 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Alcon Research Ltd
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Sponsor organisation address |
6201 S. Freeway, Fort Worth, TX, United States, 76134
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Public contact |
Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733385, Linda.masson@novartis.com
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Scientific contact |
Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733385, Linda.masson@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Feb 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to evaluate the efficacy and safety of topical Moxidex plus tympanostomy tubes (TT) for the treatment of peri-surgical tube otorrhea.
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Protection of trial subjects |
Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Dec 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 303
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Worldwide total number of subjects |
303
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
217
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Children (2-11 years) |
86
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 16 study centers located in the United States. | ||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
This reporting group includes all enrolled and treated subjects (303). | ||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Moxidex plus TT | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution
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Investigational medicinal product code |
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Other name |
Moxidex
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Pharmaceutical forms |
Ear drops, solution
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Routes of administration |
Auricular use
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Dosage and administration details |
Dosed in the affected ear(s), 4 drops twice daily (BID) for 7 days
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Arm title
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Moxifloxacin plus TT | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Moxifloxacin hydrochloride 0.5% solution
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Investigational medicinal product code |
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Other name |
Moxifloxacin
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Pharmaceutical forms |
Ear drops, solution
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Routes of administration |
Auricular use
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Dosage and administration details |
Dosed in the affected ear(s), 4 drops BID for 7 days
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Arm title
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TT only | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tympanostomy tubes
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Investigational medicinal product code |
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Other name |
TT
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Pharmaceutical forms |
Implant
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Routes of administration |
Auricular use
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Dosage and administration details |
Tubes surgically inserted through the ear drum
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was a single-masked trial and only the investigator was masked. |
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Baseline characteristics reporting groups
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Reporting group title |
Moxidex plus TT
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Reporting group description |
Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Moxifloxacin plus TT
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Reporting group description |
Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TT only
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Reporting group description |
Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Moxidex plus TT
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Reporting group description |
Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes | ||
Reporting group title |
Moxifloxacin plus TT
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Reporting group description |
Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes | ||
Reporting group title |
TT only
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Reporting group description |
Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article |
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End point title |
Time (in days) to cessation of otorrhea [1] | ||||||||||||
End point description |
The time (in days) to the cessation of otorrhea (i.e. absence of otorrhea) was calculated as the number of days from surgery to the absence of otorrhea in both ears as recorded by the subject's parent/guardian via the phone-in diary. Otorrhea was defined as ending on the first day that otorrhea was absent from both ears and remaining absent for all subsequent diary entries. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
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End point type |
Primary
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End point timeframe |
Up to Day 14 (Test of Cure (TOC))
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Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point was pre-specified for only 2 arms. |
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Statistical analysis title |
Time to cessation of otorrhea | ||||||||||||
Comparison groups |
Moxidex plus TT v TT only
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Number of subjects included in analysis |
203
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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End point title |
Percentage of subjects with clinical cure at each visit [2] | ||||||||||||||||||||||||
End point description |
Clinical cure was defined as resolved/cured (i.e. otorrhea absent) or improved/not changed or worsened (i.e. otorrhea present) as rated by the investigator at the EOT and TOC visits. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 8 (End of therapy (EOT)), Day 14 (TOC)
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Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point was pre-specified for only 2 arms. |
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Statistical analysis title |
Clinical Cure - EOT Absent | ||||||||||||||||||||||||
Comparison groups |
Moxidex plus TT v TT only
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Number of subjects included in analysis |
203
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||
P-value |
< 0.0001 | ||||||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
Clinical Cure - TOC Absent | ||||||||||||||||||||||||
Comparison groups |
Moxidex plus TT v TT only
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Number of subjects included in analysis |
203
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||
P-value |
< 0.0001 | ||||||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||||||
Confidence interval |
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End point title |
Percentage of subjects with microbiological outcome of success [3] | |||||||||||||||
End point description |
Microbiological success (i.e. eradication of pre-therapy pathogens) was reported as a percentage. This analysis population includes all subjects in the ITT population who met pre-randomization inclusion and exclusion criteria and were culture positive for bacteria on Day 1 (Modified ITT (MITT) Analysis Set). However, any ear with a baseline culture containing Group A Streptococci or yeast or fungi were excluded from the MITT population. Pre-specified for Moxidex plus TT and TT only.
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End point type |
Secondary
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End point timeframe |
Day 14 (TOC)
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Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point was pre-specified for only 2 arms. |
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No statistical analyses for this end point |
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End point title |
Percentage of subjects discontinued due to treatment failure [4] | ||||||||||||
End point description |
A subject could be considered a treatment failure at the EOT, or after, if otorrhea was confirmed by an Investigator. Reported as a percentage of subjects who discontinued due to treatment failure at any point following surgery at each follow-up visit. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
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End point type |
Secondary
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End point timeframe |
Up to Day 14 (TOC)
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Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This end point was pre-specified for only 2 arms. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All
adverse events reported in this record are from date of First Patient First Treatment until Last Patient
Last Visit.
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Adverse event reporting additional description |
This analysis population includes all subjects with successful bilateral myringotomy and TT insertion (Safety Analysis Set). Only total subjects affected by non-serious AEs that occurred at >5% are reported.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Moxidex plus TT
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Reporting group description |
Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days plus tympanostomy tube in affected ear(s) | ||||||||||||||||||||||||||||
Reporting group title |
Moxifloxacin plus TT
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Reporting group description |
Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days plus tympanostomy tube in affected ear(s) | ||||||||||||||||||||||||||||
Reporting group title |
TT only
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Reporting group description |
Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article | ||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |