NCT00706927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

4.6 years

First QC Date

June 26, 2008

Last Update Submit

November 13, 2014

Conditions

RetinaOcular Physiology

Keywords

xalacomcombiganocular blood flow

Outcome Measures

Primary Outcomes (2)

  • Optic disc blood flow measured with laser Doppler flowmeter (rel units)

    12 weeks

  • Intraocular pressure (mmHg)

    12 weeks

Secondary Outcomes (3)

  • 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

Interventions

latanoprost 0.005% + timolol 0,5% fixed combinationDRUG

1 drop per day and eye for 6 weeks

Also known as: Xalacom® (latanoprost/timolol)
brimonidine 0,2% + timolol 0,5% fixed combinationDRUG

1 drop twice a day per eye for 6 weeks

Also known as: Combigan® (brimonidine/timolol)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

LatanoprostXalacomTimololBrimonidine Tartrate, Timolol Maleate Drug CombinationBrimonidine Tartrate

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Michael Wolzt, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv. - Doz. Dr.

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 30, 2008

Study Start

January 1, 2006

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

AU(1)