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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Open-angle Glaucoma
Ocular Hypertension

Treatments

Drug: Preservative-Free Tafluprost
Drug: Comparator: timolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026831
2009_701
2452-001

Details and patient eligibility

About

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.

Enrollment

643 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

643 participants in 2 patient groups

Tafluprost
Experimental group
Description:
Preservative-free tafluprost
Treatment:
Drug: Preservative-Free Tafluprost
timolol maleate
Active Comparator group
Description:
Preservative-free timolol maleate
Treatment:
Drug: Comparator: timolol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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