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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Arezzo, Italy, 52100
        • Pfizer Investigational Site
      • Bari, Italy, 74100
        • Pfizer Investigational Site
      • Bollate, Italy
        • Pfizer Investigational Site
      • Bologna, Italy, 40133
        • Pfizer Investigational Site
      • Caserta, Italy, 81100
        • Pfizer Investigational Site
      • Catanzaro, Italy, 88100
        • Pfizer Investigational Site
      • Conegliano, Italy
        • Pfizer Investigational Site
      • Desenzano (BS), Italy, 25015
        • Pfizer Investigational Site
      • Ferrara, Italy, 44030
        • Pfizer Investigational Site
      • Livorno, Italy, 57100
        • Pfizer Investigational Site
      • Massafra, Italy, 74016
        • Pfizer Investigational Site
      • Milano, Italy, 20121
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Orbassano, Italy, 10043
        • Pfizer Investigational Site
      • Palermo, Italy, 90146
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Pescara, Italy, 65100
        • Pfizer Investigational Site
      • Ragusa, Italy, 97100
        • Pfizer Investigational Site
      • Roma, Italy, 00157
        • Pfizer Investigational Site
      • Roma, Italy, 00189
        • Pfizer Investigational Site
      • Sassari, Italy, 07100
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
IOP change from baseline to the 6-month visit.

Secondary Outcome Measures

Outcome Measure
% 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XALACO-0076-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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