Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
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
1 other identifier
interventional
240
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2005
Shorter than P25 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 18, 2021
November 1, 2006
September 12, 2005
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits
Interventions
Eligibility Criteria
You may qualify if:
- patients with open-angle glaucoma or ocular hypertension
You may not qualify if:
- closed/barely open anterior chamber angle or a history of acute angel closure glaucoma
- Ocular surgery within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Pfizer Investigational Site
Beijing, Beijing Municipality, 100034, China
Pfizer Investigational Site
Beijing, Beijing Municipality, 100730, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510060, China
Pfizer Investigational Site
Shanghai, Shanghai Municipality, 200092, China
Pfizer Investigational Site
Xi’an, Shanxi, 710004, China
Pfizer Investigational Site
Hangzhou, Zhejiang, 310003, China
Pfizer Investigational Site
Hangzhou, Zhejiang, 310009, China
Pfizer Investigational Site
Shanghai, 200031, China
Related Publications (1)
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.
PMID: 21851642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
June 1, 2005
Study Completion
September 1, 2006
Last Updated
February 18, 2021
Record last verified: 2006-11