Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

Phase 3CompletedNCT00219596

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.240 enrolled

Overview

to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Glaucoma, Open Angle Ocular Hypertension

Interventions

XalacomDRUG

unfixed Latanoprost and TimololDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with open-angle glaucoma or ocular hypertension Exclusion Criteria: * closed/barely open anterior chamber angle or a history of acute angel closure glaucoma * Ocular surgery within 3 months

Locations (8)

Pfizer Investigational Site

Beijing, Beijing Municipality, China

Pfizer Investigational Site

Beijing, Beijing Municipality, China

Pfizer Investigational Site

Guangzhou, Guangdong, China

Pfizer Investigational Site

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension

Secondary Outcomes

To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits

Data from ClinicalTrials.gov

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