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

• Status: Completed
• Trial end date: 2013-05-09
• Target enrollment: 0
• Participant gender: All

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 baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Maleic acid; Ophthalmic Solutions; Timolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.