Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

Study Overview
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Brief Summary
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The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Detailed Description
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All the patients whom an investigator prescribes the first Xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
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Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients need to be administered Xalacom® in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Xalacom®.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Latan-timolol maleate fixed comb ophthalmic solution<br> | Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution<br>* Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. One drop should be applied to the affected eye(s) once daily.<br>* Other names: Xalacom;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants WithTreatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator. | Max 104 weeks | 
| Clinical Effectiveness Rate | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks). | Max 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xalacom Regulatory post marketing commitment plan safety