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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00706927

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retina Ocular Physiology	Drug: latanoprost 0.005% + timolol 0,5% fixed combination Drug: brimonidine 0,2% + timolol 0,5% fixed combination	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Outcome Measures

Primary Outcome Measures

Optic disc blood flow measured with laser Doppler flowmeter (rel units) [12 weeks]
Intraocular pressure (mmHg) [12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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