A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.238 enrolled

Overview

To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon \& 4 PM during a 12 week treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

238

Conditions

Glaucoma, Open Angle Ocular Hypertension

Interventions

XalacomDRUG

CosoptDRUG

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 (25)

Pfizer Investigational Site

Caen, France

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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