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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 in at least one eye at the 0800
hours time point at the Baseline Visit.
- Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time
point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
- Patient is currently using a prescribed ocular hypotensive medication and has been on
a stable dose for 30 days prior to screening, or patient is drug-naive (those who
have never used or who have not used ocular hypotensive medication for at least 4
weeks prior to screening)
- Patient is able to safely discontinue current ocular hypotensive medication during up
to the 4-week washout period
- Patient has vision corrected to 20/80 or better in each eye
- Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to
dosing through 24 hour after final dosing
- Patient is willing and able to self-administer or has an able person available on a
daily basis to assist with administration of study medications
- Patient is not pregnant and not planning to become pregnant during the study
- Patient is male or female ≥18 of age on the day of signing the informed consent
Exclusion Criteria:
- Patient is unable to use study medication in the affected eye(s)
- Patient has a history of inflammatory ocular surface disease or anterior or posterior
uveitis in either eye
- Patient has a history of retinal detachment, diabetic retinopathy, or other
progressive retinal disease
- Patient has experienced significant visual field loss within the last year
- Patient has had intraocular surgery in either eye in the last 4 months
- Patient has a history of glaucoma surgery or refractive surgery in either eye
- Patient is currently taking two or more anti-glaucoma medications (except Cosoptâ„¢ or
its generic formulation)
- Patient has previously used tafluprost
- Patient has a history of cardiovascular disorder within 6 months prior to screening
- Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary
disease, or abnormal chest x-ray
- Patient has a mean (or median) IOP >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.