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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00372827

Collaborator

(none)

245

Enrollment

Location

Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma	Drug: Brinzolamide 1% added to Travoprost 0.004%	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Mean diurnal intraocular pressure at month 3 []

Secondary Outcome Measures

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. []
Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.