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

Ocular Hypertension Clinical Trial

Official title:

A Phase III, Randomized, Active Comparator-Controlled, Twelve-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma and Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026831
• Other study ID #: 2452-001
• Secondary ID: 2009_701
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2009
• Last updated: October 30, 2015
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline IOP	IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).	Baseline	No
Primary	Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)	IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).; IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).; Lowering elevated IOP is a treatment goal of glaucoma.	Baseline, Weeks 2, 6, and 12.	No