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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

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ClinicalTrials.gov Identifier: NCT00706927
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Retina Ocular Physiology Drug: latanoprost 0.005% + timolol 0,5% fixed combination Drug: brimonidine 0,2% + timolol 0,5% fixed combination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Intervention Details:
  • Drug: latanoprost 0.005% + timolol 0,5% fixed combination
    1 drop per day and eye for 6 weeks
    Other Name: Xalacom® (latanoprost/timolol)
  • Drug: brimonidine 0,2% + timolol 0,5% fixed combination
    1 drop twice a day per eye for 6 weeks
    Other Name: Combigan® (brimonidine/timolol)

Primary Outcome Measures :
  1. Optic disc blood flow measured with laser Doppler flowmeter (rel units) [ Time Frame: 12 weeks ]
  2. Intraocular pressure (mmHg) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Retrobulbar flow velocities as measured with color Doppler imaging (cm/s) [ Time Frame: 12 weeks ]
  2. Mean defect of visual field measured with automated perimetry (dB) [ Time Frame: 12 weeks ]
  3. Corneal thickness as measured with pachymetry (µm) [ Time Frame: 1 day ]

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706927

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Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Michael Wolzt, MD Department of Clinical Pharmacology, Medical University of Vienna
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Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00706927    
Other Study ID Numbers: OPHT-241005
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
ocular blood flow
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists