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

Phase 3

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension

• Registration Number: NCT00159653
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-10
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The mean IOP measurements obtained in the study eye at each time point

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada