A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

Viatris

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Xalacom; Drug: Xalatan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383019

A6641050

Details and patient eligibility

About

This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.

Enrollment: 300 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion criteria

• History of no-response to timolol
• History of trabeculectomy
• History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Xalatan

Experimental group

Treatment:

Drug: Xalatan

Xalacom

Experimental group

Treatment:

Drug: Xalacom