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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00706927
First received: June 26, 2008
Last updated: November 30, 2009
Last verified: November 2009
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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:
    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)
  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
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: 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: Michael Wolzt, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00706927     History of Changes
Other Study ID Numbers: OPHT-241005
Study First Received: June 26, 2008
Last Updated: November 30, 2009
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:
Hypertension
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Glaucoma
Eye Diseases
Timolol
Latanoprost
Brimonidine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on September 18, 2014