A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.500 enrolled

Overview

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

XalacomDRUG

XalatanDRUG

TimololDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: * Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. * History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Locations (55)

Outcomes

Primary Outcomes

The mean IOP measurements obtained in the study eye at each time point

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Poway, California, United States

Pfizer Investigational Site

Redding, California, United States

Pfizer Investigational Site

Redding, California, United States

Pfizer Investigational Site

Danbury, Connecticut, United States

Pfizer Investigational Site

Cape Coral, Florida, United States

Pfizer Investigational Site

Lakeland, Florida, United States

Pfizer Investigational Site

Ormond Beach, Florida, United States

Pfizer Investigational Site

Tampa, Florida, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

...and 45 more locations