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
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
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014