Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle

• Registration Number: NCT00140062
• Lead Sponsor: Pfizer

Brief Summary

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Study Completion: 2006-04
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-04
• Last Update Posted: 2008-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

• Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
• IOP of > 21 mm Hg on current treatment

Exclusion Criteria

• Any previous or current treatment with latanoprost or other prostaglandin analogues

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

Secondary Outcome Measures

Name	Time	Method
Safety and the health care utilization in the two treatment groups over 36 months.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Uppsala, Sweden