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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
Enrollment :	245 participants
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 :	February 2004
Actual Primary Completion Date :	January 2006
Actual Study Completion Date :	January 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mean diurnal intraocular pressure at month 3

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Mainz Site
Mainz, Germany, 55131

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:	Anna Grau	Study Manager

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted:	September 7, 2006
Last Update Posted:	November 21, 2016
Last Verified:	May 2008

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