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

NCT ID: NCT01026831

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 643 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-06
• Study Completion Date: 2010-09-17

Brief Summary

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

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

Study Groups

Tafluprost

Preservative-free tafluprost

Group Type: EXPERIMENTAL

Preservative-Free Tafluprost

Intervention Type: DRUG

One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks

timolol maleate

Preservative-free timolol maleate

Group Type: ACTIVE_COMPARATOR

Comparator: timolol

Intervention Type: DRUG

One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks

Interventions

Preservative-Free Tafluprost

One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks

Intervention Type: DRUG

Comparator: timolol

One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

MK2452

Eligibility Criteria

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.

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2012 Jun;153(6):1187-96. doi: 10.1016/j.ajo.2011.11.008. Epub 2012 Feb 4.

Reference Type: DERIVED

PMID: 22310086 (View on PubMed)

Other Identifiers

2009_701

Identifier Type: -

Identifier Source: secondary_id

2452-001

Identifier Type: -

Identifier Source: org_study_id