Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.250 enrolled

Overview

This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Glaucoma Ocular Hypertension

Interventions

XalacomDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP \>= 21 mmHG). * Visual acuity \>= 20/200. Exclusion Criteria: * Closed/barely open anterior chamber angle or history of acute angle closure glaucoma. * Hystory of ALT within 3 months prior to the baseline visit. * History of any ocular filtering surgical intervention. * Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.

Locations (21)

Pfizer Investigational Site

Arezzo, Italy

Pfizer Investigational Site

Bari, Italy

Outcomes

Primary Outcomes

IOP change from baseline to the 6-month visit.

Secondary Outcomes

% reduction of IOP change from baseline to the 6-month visit.

Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).

Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).

Data from ClinicalTrials.gov

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