At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
- ✓Mean or median IOP ≥23 and ≤36 mmHg in at least one eye at 0800 hours at Baseline Visit
- ✓IOP difference <5 mmHg between eyes at all time points (0800, 1000, 1600 hours) at Baseline
- ✓Currently using stable ocular hypotensive medication for ≥30 days prior to screening, or drug-naive with no use for ≥4 weeks
- ✕Unable to use study medication in the affected eye(s)
- ✕History of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
- ✕History of retinal detachment, diabetic retinopathy, or other progressive retinal disease
- ✕Significant visual field loss within the last year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Preservative-Free Tafluprost and Comparator: timolol for Open-angle Glaucoma and Ocular Hypertension. Completed, enrolled 643 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
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