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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00219596
First received: September 12, 2005
Last updated: September 13, 2007
Last verified: November 2006
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219596

Locations
China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 100730
Pfizer Investigational Site
Beijing, Beijing, China, 100034
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, 310009
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310003
China
Pfizer Investigational Site
Shanghai, China, 200031
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00219596     History of Changes
Other Study ID Numbers: A6641028
Study First Received: September 12, 2005
Last Updated: September 13, 2007
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 21, 2013