Expired Study
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Redding, California 96002


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

A6641027


NCT ID:

NCT00159653


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

500


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:July 2005
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 8, 2012
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The mean IOP measurements obtained in the study eye at each time point
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Xalacom
Intervention Type:Drug
Name:Xalatan
Intervention Type:Drug
Name:Timolol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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