Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002 AM1)

This study will evaluate whether Preservative-Free tafluprost is non-inferior to Preservative-Free timolol in reducing intra-ocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

• Glaucoma
• Ocular Hypertension

• Drug: Preservative-Free Tafluprost or vehicle
  One drop of Preservative-Free vehicle per eye in the morning, and one drop Preservative-Free tafluprost (0.0015%) per eye in the evening for four weeks
  Other Name: MK-2452
• Drug: Preservative-Free Timolol maleate
  One drop of Preservative-Free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks
  Other Name: Preservative-Free Timoptic

• Experimental: Tafluprost
  Preservative-Free tafluprost (0.0015%) and vehicle
  Intervention: Drug: Preservative-Free Tafluprost or vehicle
• Active Comparator: Timolol
  Preservative-Free timolol maleate (0.5%)
  Intervention: Drug: Preservative-Free Timolol maleate

Inclusion criteria:

• Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
• Patient has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
• Patient is able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 week pre-study)
• Patient has a best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
• Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours 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 with reproductive potential must use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
• Patient is able to refrigerate study drug at home.

Exclusion criteria:

• Patient has a mean IOP ≥36mm Hg in either eye at screening
• Patient is unable to use study medication in the affected eye(s)
• Patient has a history of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
• Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
• Patient has significant visual field loss or evidence of progressive visual loss with in the last year
• Patient has had intraocular surgery in either eye in the last 4 months
• Patient has had any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
• Patient is currently on 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 of screening
• Patient has a history of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.