Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002 AM1)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254604
First received: December 3, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

This study will evaluate whether Preservative-Free tafluprost is non-inferior to Preservative-Free timolol in reducing intra-ocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Preservative-Free Tafluprost or vehicle
Drug: Preservative-Free Timolol maleate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean diurnal change in IOP from baseline and Week 4 [ Time Frame: From baseline to Week 4 ] [ Designated as safety issue: No ]
    Application of one drop of the medications in the morning and one drop in the evening for four weeks


Secondary Outcome Measures:
  • Proportion of patients with≥25% reduction in IOP [ Time Frame: From baseline to Week 4 ] [ Designated as safety issue: No ]
    Application of one drop of the medications in the morning and one drop in the evening for four weeks


Enrollment: 190
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tafluprost
Preservative-Free tafluprost (0.0015%) and vehicle
Drug: Preservative-Free Tafluprost or vehicle
One drop of Preservative-Free vehicle per eye in the morning, and one drop Preservative-Free tafluprost (0.0015%) per eye in the evening for four weeks
Other Name: MK-2452
Active Comparator: Timolol
Preservative-Free timolol maleate (0.5%)
Drug: Preservative-Free Timolol maleate
One drop of Preservative-Free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks
Other Name: Preservative-Free Timoptic

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
  • Patient is able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 week pre-study)
  • Patient has a best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
  • Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours 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 with reproductive potential must use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
  • Patient is able to refrigerate study drug at home.

Exclusion criteria:

  • Patient has a mean IOP ≥36mm Hg in either eye at screening
  • Patient is unable to use study medication in the affected eye(s)
  • Patient has a history of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
  • Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
  • Patient has significant visual field loss or evidence of progressive visual loss with in the last year
  • Patient has had intraocular surgery in either eye in the last 4 months
  • Patient has had any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
  • Patient is currently on 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 of screening
  • Patient has a history of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01254604     History of Changes
Other Study ID Numbers: 2452-002
Study First Received: December 3, 2010
Last Updated: June 6, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Merck Sharp & Dohme Corp.:
Tafluprost
Glaucoma
Ocular Hypertension
Timolol
Eye Disorder
Preservative-Free
Prostaglandine Analogue

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014