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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Xalacom
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

IOP change from baseline to the 6-month visit.

Secondary Outcome Measures

% 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).

Full Information

First Posted
August 31, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143208
Brief Title
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Xalacom
Primary Outcome Measure Information:
Title
IOP change from baseline to the 6-month visit.
Secondary Outcome Measure Information:
Title
% reduction of IOP change from baseline to the 6-month visit.
Title
Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).
Title
Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
74100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bollate
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Conegliano
Country
Italy
Facility Name
Pfizer Investigational Site
City
Desenzano (BS)
ZIP/Postal Code
25015
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ferrara
ZIP/Postal Code
44030
Country
Italy
Facility Name
Pfizer Investigational Site
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Massafra
ZIP/Postal Code
74016
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ragusa
ZIP/Postal Code
97100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00157
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XALACO-0076-033&StudyName=Evaluation+Of+Intraocular+Pressure+Lowering%2DEffect+Of+Xalacom+In+Patients+With+Poag+Or+Oh%2E
Description
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Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

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