Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Preservative-Free Tafluprost; Comparator: timolol
Intervention description: 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
Intervention MeSH terms: Timolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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 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 Cosopt™ 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.