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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

Primary Purpose

Retina, Ocular Physiology

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
latanoprost 0.005% + timolol 0,5% fixed combination
brimonidine 0,2% + timolol 0,5% fixed combination
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retina focused on measuring xalacom, combigan, ocular blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2008
Last Updated
November 13, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00706927
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina, Ocular Physiology
Keywords
xalacom, combigan, ocular blood flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% + timolol 0,5% fixed combination
Other Intervention Name(s)
Xalacom® (latanoprost/timolol)
Intervention Description
1 drop per day and eye for 6 weeks
Intervention Type
Drug
Intervention Name(s)
brimonidine 0,2% + timolol 0,5% fixed combination
Other Intervention Name(s)
Combigan® (brimonidine/timolol)
Intervention Description
1 drop twice a day per eye for 6 weeks
Primary Outcome Measure Information:
Title
Optic disc blood flow measured with laser Doppler flowmeter (rel units)
Time Frame
12 weeks
Title
Intraocular pressure (mmHg)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Retrobulbar flow velocities as measured with color Doppler imaging (cm/s)
Time Frame
12 weeks
Title
Mean defect of visual field measured with automated perimetry (dB)
Time Frame
12 weeks
Title
Corneal thickness as measured with pachymetry (µm)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolzt, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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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