Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191008
• Other study ID #: A6641056
• Status: Completed
• Start date: October 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Xalacom®.

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• 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".

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.	Max 104 weeks
Primary	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
Primary	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

External Links

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