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Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

Primary Purpose

Glaucoma, Open Angle, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Xalacom
unfixed Latanoprost and Timolol
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: patients with open-angle glaucoma or ocular hypertension Exclusion Criteria: closed/barely open anterior chamber angle or a history of acute angel closure glaucoma Ocular surgery within 3 months

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

Outcomes

Primary Outcome Measures

To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension

Secondary Outcome Measures

To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits

Full Information

First Posted
September 12, 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
NCT00219596
Brief Title
Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Official Title
An 8-Week, Randomized, Open-Label, Parallel Group Study Comparing The Efficacy And Safety Of Xalacom With The Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 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 compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Xalacom
Intervention Type
Drug
Intervention Name(s)
unfixed Latanoprost and Timolol
Primary Outcome Measure Information:
Title
To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension
Secondary Outcome Measure Information:
Title
To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with open-angle glaucoma or ocular hypertension Exclusion Criteria: closed/barely open anterior chamber angle or a history of acute angel closure glaucoma Ocular surgery within 3 months
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
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Pfizer Investigational Site
City
Xi?an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Pfizer Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Pfizer Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21851642
Citation
Zhao JL, Ge J, Li XX, Li YM, Sheng YH, Sun NX, Sun XH, Yao K, Zhong Z; Xalacom Study Group in China. Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension. BMC Ophthalmol. 2011 Aug 19;11:23. doi: 10.1186/1471-2415-11-23.
Results Reference
derived

Learn more about this trial

Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

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