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

• ClinicalTrials.gov Identifier: NCT00706927
• Recruitment Status: Completed
• First Posted: June 30, 2008
• Last Update Posted: November 14, 2014
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Gerhard Garhofer, Medical University of Vienna

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: January 2006
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Intervention Details:

• Drug: latanoprost 0.005% + timolol 0,5% fixed combination
  1 drop per day and eye for 6 weeks
  Other Name: Xalacom® (latanoprost/timolol)
• Drug: brimonidine 0,2% + timolol 0,5% fixed combination
  1 drop twice a day per eye for 6 weeks
  Other Name: Combigan® (brimonidine/timolol)

Outcome Measures

Primary Outcome Measures :

1. Optic disc blood flow measured with laser Doppler flowmeter (rel units) [ Time Frame: 12 weeks ]
2. Intraocular pressure (mmHg) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Retrobulbar flow velocities as measured with color Doppler imaging (cm/s) [ Time Frame: 12 weeks ]
2. Mean defect of visual field measured with automated perimetry (dB) [ Time Frame: 12 weeks ]
3. Corneal thickness as measured with pachymetry (µm) [ Time Frame: 1 day ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Department of Clinical Pharmacology

Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

• Principal Investigator: Michael Wolzt, MD; Department of Clinical Pharmacology, Medical University of Vienna

More Information

• Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00706927
• Other Study ID Numbers: OPHT-241005
• First Posted: June 30, 2008
• Last Update Posted: November 14, 2014
• Last Verified: November 2014

Keywords provided by Gerhard Garhofer, Medical University of Vienna:

xalacom; combigan; ocular blood flow

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Brimonidine Tartrate; Latanoprost; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists