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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Preservative-Free Tafluprost; Drug: Comparator: timolol

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tafluprost; Preservative-free tafluprost	Drug: Preservative-Free Tafluprost; One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks; Other Names: MK2452
Active Comparator: timolol maleate; Preservative-free timolol maleate	Drug: Comparator: timolol; One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.	Baseline, Weeks 2, 6, and 12.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline IOP	IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).	Baseline

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2010
• Primary Completion (Actual): September 17, 2010
• Study Completion (Actual): September 17, 2010

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol
• Other Study ID Numbers: 2452-001; 2009_701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php