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.”
Condition Keyword(s):
Intervention(s):
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 October 15, 2008
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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