Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Open-angle Glaucoma Ocular Hypertension |
Drug: Preservative-Free Tafluprost Drug: Comparator: timolol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- 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) [ Time Frame: Baseline, Weeks 2, 6, and 12. ] [ Designated as safety issue: No ]
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.
| Enrollment: | 643 |
| Study Start Date: | January 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tafluprost
Preservative-free tafluprost
|
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
Other Name: MK2452
|
|
Active Comparator: timolol maleate
Preservative-free timolol maleate
|
Drug: Comparator: timolol
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01026831 History of Changes |
| Other Study ID Numbers: | MK-2452-001, 2009_701 |
| Study First Received: | December 2, 2009 |
| Results First Received: | August 9, 2011 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Maleic acid Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013