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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00372827

First received: September 6, 2006

Last updated: November 18, 2016

Last verified: May 2008

History of Changes

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Brinzolamide Travoprost

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Alcon Research:

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.


Estimated Enrollment:	245
Study Start Date:	February 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372827

Locations


Germany
Mainz Site
Mainz, Germany, 55131

Sponsors and Collaborators

Alcon Research

Investigators


Study Director:	Anna Grau	Study Manager

More Information

Publications:

Holló 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.


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00372827 History of Changes
Other Study ID Numbers:	CM-03-06
Study First Received:	September 6, 2006
Last Updated:	November 18, 2016

Additional relevant MeSH terms:


Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Travoprost Brinzolamide	Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Carbonic Anhydrase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 26, 2017

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