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Preservative-Free Tafluprost

Phase 3

Open-angle Glaucoma | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Jun 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment643

FDA Designations

No designations recorded

Clinical trial landscape

Preservative-Free Tafluprost · 1 trial · 2 indications

Phase 3 1
NCT01026831Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)Open-angle Glaucoma
COMPLETED643 Analytics
PHASE3COMPLETED
Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
Open-angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
Baseline, 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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TafluprostEXPERIMENTALPreservative-free tafluprost
timolol maleateACTIVE_COMPARATORPreservative-free timolol maleate

Interventions

NameTypeDescription
Preservative-Free TafluprostDRUGOne 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: timololDRUGOne drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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. * Patie...

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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about Preservative-Free Tafluprost

What is Preservative-Free Tafluprost used for?

Preservative-Free Tafluprost is used for the treatment of open-angle glaucoma, a condition characterized by increased pressure in the eye that can lead to optic nerve damage and vision loss. It is also being studied for ocular hypertension, a related condition involving elevated intraocular pressure. The drug is administered as an ophthalmic solution.

Who makes Preservative-Free Tafluprost?

Preservative-Free Tafluprost is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of open-angle glaucoma and ocular hypertension.

What phase is Preservative-Free Tafluprost in?

Preservative-Free Tafluprost is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities such as the U.S. Food and Drug Administration. The Phase 3 trial is designed to assess its efficacy and safety in patients with open-angle glaucoma and ocular hypertension.

What clinical trials is Preservative-Free Tafluprost in?

Preservative-Free Tafluprost is being evaluated in a Phase 3 clinical trial with the identifier NCT01026831. This randomized, double-blind, active-controlled study enrolled 643 participants aged 18 years and older with open-angle glaucoma or ocular hypertension. The trial has been completed, and its results will inform the drug's development.

Is Preservative-Free Tafluprost the same as MK2452?

Yes, Preservative-Free Tafluprost is also known as MK2452. In clinical trials, the drug is referred to by this code name, as seen in the study title 'Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)'. Both names refer to the same investigational medication developed by Merck.