Status:

COMPLETED

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

Lead Sponsor:

Medical University of Vienna

Conditions:

Retina

Ocular Physiology

Eligibility:

All Genders

18+ years

Phase:

NA

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 irreversi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT00706927

Start Date

January 1 2006

End Date

September 1 2010

Last Update

November 14 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Clinical Pharmacology

Vienna, Austria, 1090

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 | DecenTrialz