Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

NCT ID: NCT01191008

Last Updated: 2023-06-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

661 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-05-31

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.

Conditions

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Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Latan-timolol maleate fixed comb ophthalmic solution

Latanoprost-timolol maleate fixed combination ophthalmic solution

Intervention Type DRUG

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".

Interventions

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Latanoprost-timolol maleate fixed combination ophthalmic solution

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".

Intervention Type DRUG

Other Intervention Names

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Xalacom

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®.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A6641056

Identifier Type: -

Identifier Source: org_study_id

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