Efficacy and Tolerability of Xalatan in Patients (A6111128)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00950690
First received: March 31, 2009
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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 ] [ Designated as safety issue: Yes ]
    Intraocular pressure was measured at each visit

  • Humphrey Perimetry Visual Field [ Time Frame: Visits 1 and 4 ] [ Designated as safety issue: Yes ]
    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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00950690     History of Changes
Other Study ID Numbers: A6111128, A6111128
Study First Received: March 31, 2009
Results First Received: March 31, 2009
Last Updated: February 18, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Pfizer:
observational safety study

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 28, 2014