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Clinical Trials/NCT00706927
NCT00706927
Completed
Not Applicable

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

Medical University of Vienna1 site in 1 country16 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retina
Sponsor
Medical University of Vienna
Enrollment
16
Locations
1
Primary Endpoint
Optic disc blood flow measured with laser Doppler flowmeter (rel units)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
September 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr.

Medical University of Vienna

Eligibility 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
  • Congestive heart failure
  • Severe renal impairment (creatinine clearance \< 1.8 L/h)

Outcomes

Primary Outcomes

Optic disc blood flow measured with laser Doppler flowmeter (rel units)

Time Frame: 12 weeks

Intraocular pressure (mmHg)

Time Frame: 12 weeks

Secondary Outcomes

  • Retrobulbar flow velocities as measured with color Doppler imaging (cm/s)(12 weeks)
  • Mean defect of visual field measured with automated perimetry (dB)(12 weeks)
  • Corneal thickness as measured with pachymetry (µm)(1 day)

Study Sites (1)

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