Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Preservative-Free Tafluprost or vehicle; Preservative-Free Timolol maleate
Intervention description: Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug); Preservative-free timolol maleate (0.5%) ophthalmic solution
Intervention MeSH terms: Timolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Tafluprost; Glaucoma; Ocular Hypertension; Timolol; Eye Disorder; Preservative-Free; Prostaglandin Analogue

Summary:

      This study will test the hypothesis that preservative-free tafluprost (MK-2452) is
      non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular
      pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle
      glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma,
             capsular glaucoma/pseudoexfoliation, or ocular hypertension

          -  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)

          -  Able to discontinue all topical and/or systemic ocular hypotensive medication during
             the washout period (up to 4 weeks pre-study)

          -  Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of
             20/80 or better in each eye

          -  Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with
             study medication through 24 hours after final dosing

          -  Willing and able to self-administer or has an able person available on a daily basis
             to assist with administration of study medications

          -  Participant with reproductive potential must agree to remain abstinent (unless
             abstinence is not a locally acceptable method of contraception) or use highly
             effective methods of birth control (hormonal contraceptives, intrauterine device,
             diaphragm, condoms and vasectomy) within the projected duration of the study

          -  Able to refrigerate study drug at home.

        Exclusion Criteria:

          -  Mean IOP >36 mmHg in either eye at screening

          -  Unable to use study medication in the affected eye(s)

          -  History of any inflammatory ocular surface disease or a history of anterior or
             posterior uveitis in either eye within 6 months prior to screening

          -  History of retinal detachment, proliferative diabetic retinopathy, or any progressive
             retinal disease

          -  Significant visual field loss or evidence of progressive visual loss within the last
             year

          -  Intraocular surgery in either eye in the last 4 months

          -  Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye

          -  Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic
             formulation)

          -  Previously used tafluprost

          -  History of cardiovascular disorder within 6 months of screening

          -  History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or
             other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.