Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Primary Open-angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma

• Registration Number: NCT00372827
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Status Verified: 2008-05
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion Criteria

• Under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean diurnal intraocular pressure at month 3

Secondary Outcome Measures

Name	Time	Method
Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.
Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.

Trial Locations

Locations (1)

Mainz Site; 🇩🇪 Mainz, Germany