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

December 3, 2010
June 6, 2013
December 2011
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01254604 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002 AM1)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • 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
  • 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
  • Experimental: Tafluprost
    Preservative-Free tafluprost (0.0015%) and vehicle
    Intervention: Drug: Preservative-Free Tafluprost or vehicle
  • Active Comparator: Timolol
    Preservative-Free timolol maleate (0.5%)
    Intervention: Drug: Preservative-Free Timolol maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01254604
2452-002
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP