Clinical Trial Results:
An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
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Summary
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EudraCT number |
2017-002727-24 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
15 Apr 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Dec 2017
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First version publication date |
08 Dec 2017
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Other versions |
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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-10-051
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01573910 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Alcon Research
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Sponsor organisation address |
6201 S. Freeway, Fort Worth, United States, 76134
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Public contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@novartis.com
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Scientific contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@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 |
15 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Apr 2014
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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 is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
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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 |
02 May 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
China: 982
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Worldwide total number of subjects |
982
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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) |
0
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Children (2-11 years) |
17
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Adolescents (12-17 years) |
10
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Adults (18-64 years) |
897
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From 65 to 84 years |
54
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85 years and over |
4
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Recruitment
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Recruitment details |
Participants were recruited from 16 study centers located in China | |||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Of the 985 subjects who signed an informed consent for this study, 3 subjects were exited as screen failures. This reporting group includes all enrolled and randomized subjects (982). | |||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall (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 |
Assessor [1] | |||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Moxifloxacin | |||||||||||||||||||||||||||
Arm description |
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Moxifloxacin ophthalmic solution, 0.5%
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Investigational medicinal product code |
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Other name |
VIGAMOX®
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
1 drop instilled 3 times per day (TID) in each eye for 7 days
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Arm title
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Ofloxacin | |||||||||||||||||||||||||||
Arm description |
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | |||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||
Investigational medicinal product name |
Ofloxacin ophthalmic solution, 0.3%
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Investigational medicinal product code |
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Other name |
Tarivid® Eye Drops
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
1 drop instilled 3 times per day (TID) in each eye for 7 days
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| Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was a single-blind trial and only the Assessor was masked. |
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Baseline characteristics reporting groups
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Reporting group title |
Moxifloxacin
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Reporting group description |
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ofloxacin
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Reporting group description |
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Moxifloxacin
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Reporting group description |
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | ||
Reporting group title |
Ofloxacin
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Reporting group description |
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | ||
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End point title |
Clinical Cure Rate | ||||||||||||
End point description |
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
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End point type |
Primary
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End point timeframe |
Day 9
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Statistical analysis title |
Clinical Cure Rate | ||||||||||||
Comparison groups |
Moxifloxacin v Ofloxacin
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Number of subjects included in analysis |
586
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.8 | ||||||||||||
upper limit |
11.1 | ||||||||||||
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End point title |
Microbiological Success Rate | ||||||||||||
End point description |
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
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End point type |
Primary
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End point timeframe |
Day 9
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Statistical analysis title |
Microbiological Success | ||||||||||||
Comparison groups |
Moxifloxacin v Ofloxacin
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Number of subjects included in analysis |
586
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.3 | ||||||||||||
upper limit |
7.7 | ||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication.
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Adverse event reporting additional description |
An adverse event was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Moxifloxacin
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Reporting group description |
1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | ||||||||||||||||||||||||||||||
Reporting group title |
Ofloxacin
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Reporting group description |
1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | ||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events occurred above the 5% threshold. |
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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? Yes | |||
Date |
Amendment |
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12 Aug 2013 |
Added contents to the protocol in order to help better understand the efficacy of Moxifloxacin |
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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 | |||
