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Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00486252
First received: June 12, 2007
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months


Condition Intervention Phase
Glaucoma,Open-Angle
Ocular Hypertension
Other: Observational
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Intraocular Pressure (IOP): Baseline to Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage Change in Intraocular Pressure (IOP) [ Time Frame: Month 1, Month 3 ] [ Designated as safety issue: No ]
  • Categorized Percentage Change in Intraocular Pressure (IOP) [ Time Frame: Month 1, Month 3 ] [ Designated as safety issue: No ]

Enrollment: 996
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
This is N/A due to the above description.
This is N/A due to the above description.
Other: Observational
This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

  • Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
  • Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
  • Visual acuity (best corrected) equal to or better than 6/6

Exclusion Criteria:

  • closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
  • history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
  • ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
  • other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
  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: NCT00486252

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: NCT00486252     History of Changes
Other Study ID Numbers: A6111138
Study First Received: June 12, 2007
Results First Received: March 31, 2009
Last Updated: November 4, 2009
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014