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

NCT ID: NCT01254604

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-01
• Study Completion Date: 2013-05-09

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

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tafluprost

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.

Group Type: EXPERIMENTAL

Preservative-Free Tafluprost or vehicle

Intervention Type: DRUG

Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)

Timolol

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

Group Type: ACTIVE_COMPARATOR

Preservative-Free Timolol maleate

Intervention Type: DRUG

Preservative-free timolol maleate (0.5%) ophthalmic solution

Interventions

Preservative-Free Tafluprost or vehicle

Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)

Intervention Type: DRUG

Preservative-Free Timolol maleate

Preservative-free timolol maleate (0.5%) ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

MK-2452; Preservative-Free Timoptic

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.

Reference Type: RESULT

PMID: 27292765 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2452-002

Identifier Type: -

Identifier Source: org_study_id