Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT01026831|
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : September 13, 2011
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Open-angle Glaucoma Ocular Hypertension||Drug: Preservative-Free Tafluprost Drug: Comparator: timolol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||643 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||January 6, 2010|
|Primary Completion Date :||September 17, 2010|
|Study Completion Date :||September 17, 2010|
U.S. FDA Resources
Drug: Preservative-Free Tafluprost
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
Other Name: MK2452
Active Comparator: timolol maleate
Preservative-free timolol maleate
Drug: Comparator: timolol
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
- 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) [ Time Frame: Baseline, 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 IOP [ Time Frame: Baseline ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026831
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|