Clinical Trial Results:
Assessing the Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (travoprost 0.004%) versus LUMIGAN® 0.01% Solution with BAK (bimatoprost 0.01%) in Treatment Naïve patients with Ocular Hypertension or Open Angle Glaucoma
Summary
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EudraCT number |
2012-002078-30 |
Trial protocol |
SI |
Global end of trial date |
18 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
05 Aug 2015
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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 |
RDG-11-244
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01664039 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Not available: Not available | ||
Sponsors
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Sponsor organisation name |
Alcon Research, Ltd.
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Sponsor organisation address |
6201 South Freeway, Fort Worth, United States, 76134
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Public contact |
Global Brand Lead, Medical Affairs, Glaucoma, Alcon Research, Ltd., 1 888-451-3937, alcon.medinfo@alcon.com
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Scientific contact |
Global Brand Lead, Medical Affairs, Glaucoma, Alcon Research, Ltd., 1 888-451-3937, alcon.medinfo@alcon.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Jun 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 objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative versus LUMIGAN® 0.01% Solution with BAK in treatment naïve patients with ocular hypertension or open angle glaucoma.
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Protection of trial subjects |
This study was performed in compliance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice (GCP). An Ethics Committee reviewed and approved (for use in this study) informed consent form was read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2012
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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 |
Slovenia: 104
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Worldwide total number of subjects |
104
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EEA total number of subjects |
104
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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) |
0
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Adults (18-64 years) |
69
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From 65 to 84 years |
34
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85 years and over |
1
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Recruitment
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Recruitment details |
Subjects were enrolled at 2 study centers in Slovenia | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
The study population included males and females of any race/ethnicity who were older than 18 years of age and who had newly diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and were treatment naïve to any glaucoma treatment. | ||||||||||||||||||||||||
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 |
Investigator [1] | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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TRAVATAN | ||||||||||||||||||||||||
Arm description |
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
TRAVATAN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ear drops, solution
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Routes of administration |
Ocular use
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Dosage and administration details |
One drop to the study eye(s), once a day in the evening, for 6 months
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Arm title
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LUMIGAN | ||||||||||||||||||||||||
Arm description |
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK) | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
LUMIGAN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ocular use
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Dosage and administration details |
One drop to the study eye(s), once a day in the evening, for 6 months
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: The observer was masked in this study. |
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Baseline characteristics reporting groups
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Reporting group title |
TRAVATAN
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Reporting group description |
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LUMIGAN
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Reporting group description |
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
TRAVATAN
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Reporting group description |
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative | ||
Reporting group title |
LUMIGAN
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Reporting group description |
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK) |
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End point title |
Mean Change from Baseline in Intraocular Pressure (IOP) at Month 6 | ||||||||||||||||||
End point description |
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. This analysis population includes all randomized subjects who received at least one dose of either study treatment and had at least one post-baseline on-therapy study visit. Here, n=the number of subjects with non-missing values at the specific timepoint for each arm group respectively.
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End point type |
Primary
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End point timeframe |
Baseline, Month 6
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Statistical analysis title |
Analysis of Change from Baseline in IOP at Month 6 | ||||||||||||||||||
Comparison groups |
TRAVATAN v LUMIGAN
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Number of subjects included in analysis |
99
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||||
P-value |
= 0.544 | ||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||
Point estimate |
-0.419
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-1.789 | ||||||||||||||||||
upper limit |
0.951 | ||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.689
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events were collected for the duration of the study (September 2012 to June 2014). This analysis population includes all subjects who received at least one dose of either study treatment.
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Adverse event reporting additional description |
An Adverse Event (AE) 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. AEs were obtained as both volunteered and elicited comments from the study subjects.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
TRAVATAN
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Reporting group description |
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative, | ||||||||||||||||||||||||||||||
Reporting group title |
LUMIGAN
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Reporting group description |
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK) | ||||||||||||||||||||||||||||||
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: There were no non-serious adverse events occurring above a threshold of 5% in either arm in this study. |
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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 |