Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)

• Status: Completed
• Trial end date: 2010-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Maleic acid; Timolol

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.