Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated...

Date First Received: August 29, 2005

Last Updated: April 4, 2008

Verified by: Pfizer, April 2008

Clinical Trial Phase: Phase 4 | Start Date: February 2002

Overall Status: Completed

Estimated Enrollment: 329

Brief Summary

Official Title: “A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension”

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: latanoprost 0.005% (Xalatan)

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

Secondary Measures

  • Safety and the health care utilization in the two treatment groups over 36 months.

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
  • IOP of > 21 mm Hg on current treatment

Exclusion Criteria:

  • Any previous or current treatment with latanoprost or other prostaglandin analogues

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

Clinical Trial Sponsor Information

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140062

Study ID Number: 912-OPT-0091-156

ClinicalTrials.gov Identifier: NCT00140062

Health Authority: Sweden: Medical Products Agency

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Link to ClinicalStudyResults.org posting

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