Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
1 other identifier
interventional
250
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2003
Typical duration for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFebruary 21, 2021
January 1, 2008
August 31, 2005
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
IOP change from baseline to the 6-month visit.
Secondary Outcomes (3)
% 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).
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP \>= 21 mmHG).
- Visual acuity \>= 20/200.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Pfizer Investigational Site
Arezzo, 52100, Italy
Pfizer Investigational Site
Bari, 74100, Italy
Pfizer Investigational Site
Bollate, Italy
Pfizer Investigational Site
Bologna, 40133, Italy
Pfizer Investigational Site
Caserta, 81100, Italy
Pfizer Investigational Site
Catanzaro, 88100, Italy
Pfizer Investigational Site
Conegliano, Italy
Pfizer Investigational Site
Desenzano (BS), 25015, Italy
Pfizer Investigational Site
Ferrara, 44030, Italy
Pfizer Investigational Site
Livorno, 57100, Italy
Pfizer Investigational Site
Massafra, 74016, Italy
Pfizer Investigational Site
Milan, 20121, Italy
Pfizer Investigational Site
Napoli, 80131, Italy
Pfizer Investigational Site
Orbassano, 10043, Italy
Pfizer Investigational Site
Palermo, 90146, Italy
Pfizer Investigational Site
Pavia, 27100, Italy
Pfizer Investigational Site
Pescara, 65100, Italy
Pfizer Investigational Site
Ragusa, 97100, Italy
Pfizer Investigational Site
Roma, 00157, Italy
Pfizer Investigational Site
Roma, 00189, Italy
Pfizer Investigational Site
Sassari, 07100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
May 1, 2003
Study Completion
April 1, 2006
Last Updated
February 21, 2021
Record last verified: 2008-01