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

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”

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

Intervention(s) in this Clinical Trial

• Other: Observational
  • This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

Arms, Groups and Cohorts in this Clinical Trial

• : This is N/A due to the above description.
  • This is N/A due to the above description.

Primary Measures

• Change in Intraocular Pressure (IOP): Baseline to Month 3
  • Time Frame: Baseline, Month 3
    Safety Issue?: No

Secondary Measures

• Percentage Change in Intraocular Pressure (IOP)
  • Time Frame: Month 1, Month 3
    Safety Issue?: No
• Categorized Percentage Change in Intraocular Pressure (IOP)
  • Time Frame: Month 1, Month 3
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486252

Study ID Number: A6111138

ClinicalTrials.gov Identifier: NCT00486252

Health Authority: Czech Republic: State Institute for Drug Control

To obtain contact information for a study center near you, click here.