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

Viatris

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Timolol; Drug: Xalatan; Drug: Xalacom

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159653

A6641027

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind