NCT01191008

Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 661 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2010-08-30
• Last updated: 2023-06-01
• Results posted: 2017-07-17