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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-angle Glaucoma; Ocular Hypertension

Intervention: Preservative-Free Tafluprost (Drug); Comparator: timolol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: A Phase III, Randomized, Active Comparator-Controlled, Twelve-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma and Ocular Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 Cosoptâ„¢ 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.

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: November 20, 2014

Page last updated: August 23, 2015

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