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

Primary Purpose

Glaucoma, Open Angle, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Xalacom
Cosopt
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, Open Angle

Eligibility Criteria

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 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
NCT00140049
Brief Title
A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
Official Title
A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
238 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Xalacom
Intervention Type
Drug
Intervention Name(s)
Cosopt
Primary Outcome Measure Information:
Title
The mean IOP measurements obtained in the study eye at each time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Pfizer Investigational Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Pfizer Investigational Site
City
Darmstadt
ZIP/Postal Code
64297
Country
Germany
Facility Name
Pfizer Investigational Site
City
Landau / Pfalz
ZIP/Postal Code
76829
Country
Germany
Facility Name
Pfizer Investigational Site
City
Regenstauf
ZIP/Postal Code
93128
Country
Germany
Facility Name
Pfizer Investigational Site
City
Schorndorf
ZIP/Postal Code
73614
Country
Germany
Facility Name
Pfizer Investigational Site
City
Starnberg
ZIP/Postal Code
82319
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Pfizer Investigational Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Pfizer Investigational Site
City
Larisa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Monza (MI)
ZIP/Postal Code
20052
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
ZIP/Postal Code
431 80
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
örebro
ZIP/Postal Code
703 61
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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