Phase 3
Completed N=643
Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
Source: ClinicalTrials.gov NCT01026831 ↗Enrolled (actual)
643
Serious AEs
1.4%
Results posted
Sep 2011
Primary outcomePrimary: 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) — -7.1; -6.8; -6.8; -6.1 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-7.1; -6.8; -6.8; -6.1; -6.2; -5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
- Patient has a mean (or median) IOP of >=23 and = 36 mmHg in either eye at the Screening Visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.
Data sourced from ClinicalTrials.gov (NCT01026831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.