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

Study Type: Observational

Study Design: Case Control, Prospective

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Other: Behavioral
  • This is a non-interventional study.

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

• The primary endpoint is the IOP change from baseline to the 3 months visit in each group of patients (naive patients, patients with beta-blockers therapy failure) separately.
  • Time Frame: 3 month
    Safety Issue?: No

Secondary Measures

• The percentage reduction of IOP from baseline to the 3 months visit in each group of patients (naive patients, patients with beta-blockers therapy failure) separately.
  • Time Frame: 3 month
    Safety Issue?: No
• The proportion of patients achieving different levels of mean % reduction in IOP at the end of treatment (e.g., 0%, 10%, 15%, 20%…etc) in each group of patients (naive patients, patients with beta-blockers therapy failure)
  • Time Frame: 3 month
    Safety Issue?: No
• separately.
  • Time Frame: 3 month
    Safety Issue?: No

Inclusion Criteria:

• Unilateral or bilateral open angle glaucoma or ocular hypertension
• 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
• Minimum of 18 years of age

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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

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.