A Phase III, Randomized, Active Comparator-Controlled, Twelve-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma and Ocular Hypertension
Sponsor study identifier
Secondary identifiers
interventional
643
0 countries
N/A
Study Start
January 6, 2010
Actual (reported)Primary Completion
September 17, 2010
Actual (reported)Study Completion
September 17, 2010
Actual (reported)This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 17, 2010
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2009
Actual (reported)December 4, 2009
Actual (reported)January 6, 2010
Actual (reported)September 17, 2010
Actual (reported)September 17, 2010
Actual (reported)September 13, 2011
Actual (reported)Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.
Baseline, Weeks 2, 6, and 12.
Baseline IOP
Baseline
Preservative-free tafluprost
Preservative-free timolol maleate
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2012 Jun;153(6):1187-96. doi: 10.1016/j.ajo.2011.11.008. Epub 2012 Feb 4.
Medical Monitor
Merck Sharp & Dohme LLC
643 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2009
First Posted
December 4, 2009
Study Start
January 6, 2010
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 17, 2010
Actual (reported)Study Completion
September 17, 2010
Actual (reported)Last Updated
June 21, 2017
Results First Posted
September 13, 2011
Record last verified: 2017-05
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
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Source: ClinicalTrials.gov.
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