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

Study Overview
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Brief Summary
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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.

Official Title
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A 8-WEEK, RANDOMIZED, DOUBLE-MASKED, PARALLEL GROUP, PHASE III STUDY COMPARING THE EFFICACY AND SAFETY OF XALACOM AND XALATAN IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA (POAG) OR OCULAR HYPERTENSION (OH)

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Xalatan
* Drug: Xalacom


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xalatan<br> | Drug: Xalatan<br>* latanoprost 0.005%, one rop once daily in evening<br>|
| Experimental: Xalacom<br> | Drug: Xalacom<br>* latanoprost 0.005% adn timolol 0.5%, one drop, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Value at Week 8 minus value at baseline | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IOP From Baseline to Week 4 | Value at Week 4 minus value at baseline | 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 | 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 | 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 | 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 | 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 | 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 | Baseline to Week 8 | 
| Number of Subjects With an IOP of <=17 mmHg at Week 8 | Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8 | Week 8 |