Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom (Fixed Combination Of Latanoprost And Timolol) In Patients With Poag Or Oh. A 6-Month, Open, Multi-Center Trial In Italy

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country250 target enrollmentMay 2003

ConditionsGlaucoma Ocular Hypertension

DrugsXalacom

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 250
Locations: 1
Primary Endpoint: IOP change from baseline to the 6-month visit.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

April 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

IOP change from baseline to the 6-month visit.

Secondary Outcomes

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