Clinical trial NCT01026831: Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline, Weeks 2, 6, and 12.
Secondary outcomes:
Other outcomes:
measure: Baseline IOP
timeFrame: Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2012 Jun;153(6):1187-96. doi: 10.1016/j.ajo.2011.11.008. Epub 2012 Feb 4.