Overview

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 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.