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Efficacy and Tolerability of Xalatan in Patients (A6111128)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 3, 2009
Last Update Posted: February 23, 2011
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:
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: Xalatan 0.005% eye drops Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment ]
    Intraocular pressure was measured at each visit

  • Humphrey Perimetry Visual Field [ Time Frame: Visits 1 and 4 ]
    Analysis of visual field deficits for abnormalities.

Enrollment: 1289
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Drug - Xalatan 0.005% eye drops Drug: Xalatan 0.005% eye drops
ophthalmic solution dosed once daily for 3 months
Other Name: latanoprost

Detailed Description:
  • Efficacy data not collected or analyzed
  • Safety and tolerability of Xalatan assessed NA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adults with glauocma or ocular hypertension

Inclusion Criteria:

  • Patient with ocular hypertension at least 22mg Hg
  • Patient must be over 18 years old

Exclusion Criteria:

  • None listed in the protocol
  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): NCT00950690

Pfizer Investigational Site
Alexandria, Egypt
Saudi Arabia
Pfizer Investigational Site
Jeddah, Saudi Arabia
United Arab Emirates
Pfizer Investigational Site
Umm Al Quwain, United Arab Emirates
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00950690     History of Changes
Other Study ID Numbers: A6111128
First Submitted: March 31, 2009
First Posted: August 3, 2009
Results First Submitted: March 31, 2009
Results First Posted: August 3, 2009
Last Update Posted: February 23, 2011
Last Verified: February 2011

Keywords provided by Pfizer:
observational safety study

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents