Clinical Trial Results:
An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
Summary
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EudraCT number |
2017-002732-17 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
09 Feb 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jan 2018
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First version publication date |
04 Jan 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-05-04
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00579020 | ||
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, Texas, United States, 76134
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Public contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, dennis.wong@novartis.com
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Scientific contact |
Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, 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 |
09 Feb 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Feb 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Feb 2009
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Was the trial ended prematurely? |
Yes
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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 Moxidex Ophthalmic Solution for the treatment of marginal corneal infiltrates.
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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 |
10 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: 144
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Worldwide total number of subjects |
144
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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) |
0
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Adolescents (12-17 years) |
14
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Adults (18-64 years) |
118
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From 65 to 84 years |
11
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85 years and over |
1
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Recruitment
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Recruitment details |
Subjects were recruited from 26 study centers located in US. | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
This reporting group includes all enrolled and randomized subjects (144). | ||||||||||||||||||||||||||||||||||||
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 |
Double blind [1] | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Assessor | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Moxidex | ||||||||||||||||||||||||||||||||||||
Arm description |
Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Moxifloxacin Ophthalmic Solution 0.5%/dexamethasone phosphate 0.1%
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Investigational medicinal product code |
FID 107535
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Other name |
Moxidex
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Topical use , Ocular use
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Dosage and administration details |
Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids
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Arm title
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Moxifloxacin | ||||||||||||||||||||||||||||||||||||
Arm description |
Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | ||||||||||||||||||||||||||||||||||||
Arm type |
Reference Comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Moxifloxacin Ophthalmic Solution 0.5%
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Investigational medicinal product code |
FID 106489
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Other name |
Moxifloxacin
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ocular use, Topical use
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Dosage and administration details |
Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids
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Arm title
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Dexamethasone | ||||||||||||||||||||||||||||||||||||
Arm description |
Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | ||||||||||||||||||||||||||||||||||||
Arm type |
Reference Comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dexamethasone Phosphate Solution 0.1%
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Investigational medicinal product code |
FID 107595
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ocular use, Topical use
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Dosage and administration details |
Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids
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Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: In this study, treatments were double-masked, unknown to the subject and the clinical assessor. |
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Baseline characteristics reporting groups
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Reporting group title |
Moxidex
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Reporting group description |
Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Moxifloxacin
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Reporting group description |
Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dexamethasone
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Reporting group description |
Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Moxidex
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Reporting group description |
Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | ||
Reporting group title |
Moxifloxacin
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Reporting group description |
Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. | ||
Reporting group title |
Dexamethasone
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Reporting group description |
Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days. |
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End point title |
Resolution of Corneal Stromal Infiltrates at Day 10 (Test of Cure [TOC]) [1] | ||||||||||||||||
End point description |
Resolution (complete clearing) of corneal stromal infiltrate(s)) was defined by its absence in the study eye at Day 10, regardless of the presence of scarring or haze. Reported as a percentage of total subjects with resolution.
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End point type |
Primary
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End point timeframe |
Day 10 (TOC)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to cancellation of the study, no inferential statistical analyses were performed. Descriptive statistics only were presented for the primary efficacy variable. |
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Notes [2] - All subjects who received treatment (Safety Analysis Set) with non-missing data at TOC [3] - Safety Analysis Set with non-missing data at TOC [4] - Safety Analysis Set with non-missing data at TOC |
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No statistical analyses for this end point |
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End point title |
Microbiological Success at Day 10 (TOC) | ||||||||||||||||
End point description |
Microbiological success was defined as eradication of all pre-therapy bacteria from the lid of the study eye at the Day 10 (TOC) visit. Reported as a percentage of total subjects with success. This analysis population, a culture positive subset of the safety analysis set, includes all subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline.
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End point type |
Secondary
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End point timeframe |
Day 10 (TOC)
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Notes [5] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline. [6] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline. [7] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline. |
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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 |
Only total subjects affected by non-serious AEs that occur 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 |
11.0
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Reporting groups
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Reporting group title |
Moxidex
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Moxifloxacin
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Dexamethasone
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Reporting group description |
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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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05 Nov 2007 |
To change the primary efficacy variable based on recommendation from Health Authority |
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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. | |||
Study was terminated due to lack of sufficient efficacy and not related to safety. Subjects currently enrolled at the time of termination were allowed to complete their remaining study visits. |