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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Glaucoma Ocular Hypertension

Interventions

XalatanDRUG

latanoprost 0.005%, one rop once daily in evening

XalacomDRUG

latanoprost 0.005% adn timolol 0.5%, one drop, once daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (54)

Outcomes

Primary Outcomes

Change of Intraocular Pressure (IOP) From Baseline to Week 8

Value at Week 8 minus value at baseline

Time frame: Baseline to Week 8

Secondary Outcomes

Change of IOP From Baseline to Week 4

Value at Week 4 minus value at baseline

Time frame: Baseline to Week 4

Number of Subjects With an IOP of <=15 mmHg at Week 8

Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8

Time frame: Week 8

Number of Subjects With an IOP of <=16 mmHg at Week 8

Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8

Time frame: Week 8

Percent Change of IOP From Baseline to Week 8

Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100

Time frame: Baseline to Week 8

Number of Subjects With an IOP of <=18 mmHg at Week 8

Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8

Time frame: Week 8

Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8

Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline

Time frame: Baseline to Week 8

Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8

Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline

Data from ClinicalTrials.gov

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