Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution

• Registration Number: NCT01191008
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2010-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-12-22
• Status Verified: 2017-02
• Results First Submitted QC: 2017-04-17
• Results First Posted: 2017-07-17
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

Inclusion Criteria

• Patients need to be administered Xalacom® in order to be enrolled in the surveillance.

Exclusion Criteria

• Patients not administered Xalacom®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Latan-timolol maleate fixed comb ophthalmic solution	Latanoprost-timolol maleate fixed combination ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Clinical Effectiveness Rate	Max 104 weeks	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).
Number of Participants WithTreatment-Related Adverse Events	Max 104 weeks	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.