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Efficacy and Tolerability of Xalatan in Patients (A6111128)

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ClinicalTrials.gov Identifier: NCT00950690
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : August 3, 2009
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

Condition or disease Intervention/treatment
Glaucoma Ocular Hypertension Drug: Xalatan 0.005% eye drops

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

Study Type : Observational
Actual Enrollment : 1289 participants
Time Perspective: Prospective
Official Title: Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.
Study Start Date : July 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007


Group/Cohort Intervention/treatment
Study Drug - Xalatan 0.005% eye drops Drug: Xalatan 0.005% eye drops
ophthalmic solution dosed once daily for 3 months
Other Name: latanoprost



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

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



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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None listed in the protocol

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


Locations
Egypt
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00950690     History of Changes
Other Study ID Numbers: A6111128
First Posted: August 3, 2009    Key Record Dates
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:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Latanoprost
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents