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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Open-angle Glaucoma

Ocular Hypertension

Treatments

Drug: Preservative-Free Tafluprost

Drug: Comparator: timolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026831

2009_701

2452-001

Details and patient eligibility

About

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.

Enrollment

643 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.