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

Ocular Physiology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706927
• Other study ID #: OPHT-241005
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: November 13, 2014
• Start date: January 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Ocular Physiology
• Retina

Intervention

Drug:
• latanoprost 0.005% + timolol 0,5% fixed combination
1 drop per day and eye for 6 weeks
• brimonidine 0,2% + timolol 0,5% fixed combination
1 drop twice a day per eye for 6 weeks

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic disc blood flow measured with laser Doppler flowmeter (rel units)		12 weeks	No
Primary	Intraocular pressure (mmHg)		12 weeks	No
Secondary	Retrobulbar flow velocities as measured with color Doppler imaging (cm/s)		12 weeks	No
Secondary	Mean defect of visual field measured with automated perimetry (dB)		12 weeks	No
Secondary	Corneal thickness as measured with pachymetry (µm)		1 day	No