Status:
COMPLETED
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from ...
Eligibility Criteria
Inclusion
- Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
- 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)
- Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
- Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
- Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
- Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
- Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
- Able to refrigerate study drug at home.
Exclusion
- Mean IOP \>36 mmHg in either eye at screening
- Unable to use study medication in the affected eye(s)
- History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
- History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
- Significant visual field loss or evidence of progressive visual loss within the last year
- Intraocular surgery in either eye in the last 4 months
- Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
- Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
- Previously used tafluprost
- History of cardiovascular disorder within 6 months of screening
- History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2013
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01254604
Start Date
December 1 2011
End Date
May 9 2013
Last Update
September 20 2018
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