A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

Pfizer

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Xalacom

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150267

912-OPT-0076-019

Details and patient eligibility

About

To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.

Enrollment: 976 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers

Exclusion criteria

• Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)