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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Preservative-Free Tafluprost or vehicle; Drug: Preservative-Free Timolol maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254604

2452-002

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

Tafluprost

Experimental group

Description:

One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm.

Treatment:

Drug: Preservative-Free Tafluprost or vehicle

Timolol

Active Comparator group

Description:

One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.

Treatment:

Drug: Preservative-Free Timolol maleate