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Completed

NCT Number: NCT00706927

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

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.

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Key information

Conditions

Retina Ocular Physiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

latanoprost 0.005% + timolol 0,5% fixed combination

Drug

1 drop per day and eye for 6 weeks

Other names: Xalacom® (latanoprost/timolol)

brimonidine 0,2% + timolol 0,5% fixed combination

Drug

1 drop twice a day per eye for 6 weeks

Other names: Combigan® (brimonidine/timolol)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2008
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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