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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219596
First Posted: September 22, 2005
Last Update Posted: September 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

Condition Intervention Phase
Glaucoma, Open Angle Ocular Hypertension Drug: Xalacom Drug: unfixed Latanoprost and Timolol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 240
Study Start Date: June 2005
Study Completion Date: September 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219596


Locations
China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 100034
Pfizer Investigational Site
Beijing, Beijing, China, 100730
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510060
China, Shanghai
Pfizer Investigational Site
Shanghai, Shanghai, China, 200092
China, Shanxi
Pfizer Investigational Site
Xi?an, Shanxi, China, 710004
China, Zhejiang
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310003
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310009
China
Pfizer Investigational Site
Shanghai, China, 200031
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00219596     History of Changes
Other Study ID Numbers: A6641028
First Submitted: September 12, 2005
First Posted: September 22, 2005
Last Update Posted: September 14, 2007
Last Verified: November 2006

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents