Effect of Xalacom® (Latanoprost/Timolol) and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00706927

Purpose

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. The main focus of glaucoma is still directed towards a decrease in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan® (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as their ocular hemodynamic effects.

Condition	Intervention
Retina Ocular Physiology	Drug: latanoprost 0.005% + timolol 0,5% fixed combination Drug: brimonidine 0,2% + timolol 0,5% fixed combination

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-masked Randomized Cross-over Study Comparing of the Effect of Xalacom® (Latanoprost/Timolol)and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate Latanoprost

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Optic disc blood flow measured with laser Doppler flowmeter (rel units) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Intraocular pressure (mmHg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retrobulbar flow velocities as measured with color Doppler imaging (cm/s) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean defect of visual field measured with automated perimetry (dB) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Corneal thickness as measured with pachymetry (µm) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2006
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

1 drop per day and eye for 6 weeks

1 drop twice a day per eye for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women over 18 years
Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP between 22 -35mmHg
At least 3 reliable visual field testings
4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors

Exclusion Criteria:

History of acute angle closure
Closed or barely open anterior chamber angle
Mean deviation of visual field testing > 10
Intraocular surgery or argon laser trabeculoplasty within the last six months
Ocular inflammation or infection within the last three months
Contact lenses
Patients with bradycardia (heart rate < 50 beats/min)
Second and third degree heart block
Asthma
COPD
Congestive heart failure
Severe renal impairment (creatinine clearance < 1.8 L/h)
History of hypersensitivity to one of the study drugs or drugs with similar chemical structure
Topical or systematically/oral therapy with steroids
History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706927

Contacts

Contact: Gerhard Garhöfer, MD

43-14-0400-2981

gerhard.garhoefer@meduniwien.ac.at

Locations

Austria
Department of Clinical Pharmacology	Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhöfer, MD 43-14-0400-2981 gerhard.garhoefer@meduniwien.ac.at

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Michael Wolzt, MD

Department of Clinical Pharmacology, Medical University of Vienna

More Information

No publications provided

Responsible Party:	Medical University of Vienna ( Michael Wolzt )
Study ID Numbers:	OPHT-241005
Study First Received:	June 26, 2008
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00706927 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

xalacom
combigan
ocular blood flow

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Adrenergic Agonists
Pharmacologic Actions

Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010