A 12-Week, Randomized, Double-Masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

To demonstrate statistical superiority of the combination of latanaopost and timolol to the indivitual therapy of latanoprost and timlol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12...

Date First Received: January 13, 2006

Last Updated: June 24, 2008

Verified by: Pfizer, June 2008

Clinical Trial Phase: Phase 3 | Start Date: December 2005

Overall Status: Completed

Estimated Enrollment: 528

Brief Summary

Official Title: “A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension In The United States.”

To demonstrate statistical superiority of the combination of latanaopost and timolol to the indivitual therapy of latanoprost and timlol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Xalacom
  • Drug: Xalatan
  • Drug: Timolol

Outcome Measures for this Clinical Trial

Primary Measures

  • The mean IOP measurements obtained in the study eye at each time point.

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

  • Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
  • History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277498

Study ID Number: A6641044

ClinicalTrials.gov Identifier: NCT00277498

Health Authority: United States: Food and Drug Administration

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Link to ClinicalStudyResults.org posting.

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