NCT00372827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
Last Updated

November 21, 2016

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

September 6, 2006

Last Update Submit

November 18, 2016

Conditions

Primary Open-angle GlaucomaOcular HypertensionPigment Dispersion Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal intraocular pressure at month 3

Secondary Outcomes (3)

  • 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.

Interventions

Brinzolamide 1% added to Travoprost 0.004%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mainz Site

Mainz, 55131, Germany

Location

Related Publications (1)

  • Hollo G, Chiselita D, Petkova N, Cvenkel B, Liehneova I, Izgi B, Berta A, Szaflik J, Turacli E, Stewart WC. The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma. Eur J Ophthalmol. 2006 Nov-Dec;16(6):816-23. doi: 10.1177/112067210601600606.

    PMID: 17191187RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Anna Grau

    Study Manager

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

February 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 21, 2016

Record last verified: 2008-05

Locations

DE(1)