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NCT00219596 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219596
Other study ID # A6641028
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2005
Est. completion date September 2006

Study information
Verified date November 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xalacom

• unfixed Latanoprost and Timolol

Locations
Country Name City State
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Hangzhou Zhejiang
China Pfizer Investigational Site Hangzhou Zhejiang
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai Shanghai
China Pfizer Investigational Site Xi?an Shanxi

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits
See also
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