Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01026831
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : September 13, 2011
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Preservative-Free Tafluprost Drug: Comparator: timolol Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 643 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 6, 2010
Actual Primary Completion Date : September 17, 2010
Actual Study Completion Date : September 17, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: 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




Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline, 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.



Other Outcome Measures:
  1. Baseline IOP [ Time Frame: Baseline ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026831


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01026831    
Other Study ID Numbers: 2452-001
2009_701
First Posted: December 4, 2009    Key Record Dates
Results First Posted: September 13, 2011
Last Update Posted: June 21, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents