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NCT00159653 Clinical Trial

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

Ocular Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159653
Other study ID # A6641027
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2005
Est. completion date June 2007

Study information
Verified date October 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xalacom

• Xalatan

• Timolol

Locations
Country Name City State
Canada Pfizer Investigational Site Barrie Ontario
Canada Pfizer Investigational Site Bridgewater Nova Scotia
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Markham Ontario
Canada Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Moncton New Brunswick
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Nanaimo British Columbia
Canada Pfizer Investigational Site Oakville Ontario
Canada Pfizer Investigational Site Saint John New Brunswick
Canada Pfizer Investigational Site Saint John New Brunswick
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
United States Pfizer Investigational Site Amarillo Texas
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Bethpage New York
United States Pfizer Investigational Site Cape Coral Florida
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cranberry Township Pennsylvania
United States Pfizer Investigational Site Danbury Connecticut
United States Pfizer Investigational Site High Point North Carolina
United States Pfizer Investigational Site Homewood Illinois
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Lakeland Florida
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Matthews North Carolina
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Morrow Georgia
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newark New Jersey
United States Pfizer Investigational Site North Charleston South Carolina
United States Pfizer Investigational Site North Dartmouth Massachusetts
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Ormond Beach Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Poway California
United States Pfizer Investigational Site Redding California
United States Pfizer Investigational Site Redding California
United States Pfizer Investigational Site Saint Joseph Michigan
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The mean IOP measurements obtained in the study eye at each time point
See also
  Status Clinical Trial Phase
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4

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