RetinaNCT00706927
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
A study testing latanoprost 0.005% + timolol 0,5% fixed combination and brimonidine 0,2% + timolol 0,5% fixed combination in people with Retina and Ocular Physiology, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retina, Ocular Physiology
- What is being tested?
- latanoprost 0.005% + timolol 0,5% fixed combination and brimonidine 0,2% + timolol 0,5% fixed combination
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2006to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Retina, Ocular Physiology
- Being tested
- latanoprost 0.005% + timolol 0,5% fixed combination, brimonidine 0,2% + timolol 0,5% fixed combination
- Keywords
- xalacom, combigan, ocular blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latanoprost 0.005% + timolol 0,5% fixed combinationDrug
Also called Xalacom® (latanoprost/timolol)
1 drop per day and eye for 6 weeks
brimonidine 0,2% + timolol 0,5% fixed combinationDrug
Also called Combigan® (brimonidine/timolol)
1 drop twice a day per eye for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic disc blood flow measured with laser Doppler flowmeter (rel units)
Measured: 12 weeks
Intraocular pressure (mmHg)
Measured: 12 weeks
Secondary outcomes (3)
Retrobulbar flow velocities as measured with color Doppler imaging (cm/s)
Measured: 12 weeks
Mean defect of visual field measured with automated perimetry (dB)
Measured: 12 weeks
Corneal thickness as measured with pachymetry (µm)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Michael Wolzt, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706927
- Sponsor's protocol ID
- OPHT-241005
- Status last verified
- Nov 2014
- First submitted
- 26 Jun 2008
- Last updated
- 14 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00706927
- Acronym / sponsor ID
- OPHT-241005
- Conditions
- Retina, Ocular Physiology
- Keywords
- xalacom, combigan, ocular blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| latanoprost 0.005% + timolol 0,5% fixed combinationAlso: Xalacom® (latanoprost/timolol)1 drop per day and eye for 6 weeks | Drug | – |
| brimonidine 0,2% + timolol 0,5% fixed combinationAlso: Combigan® (brimonidine/timolol)1 drop twice a day per eye for 6 weeks | Drug | – |
Primary outcome
Optic disc blood flow measured with laser Doppler flowmeter (rel units)
Time frame: 12 weeks
Intraocular pressure (mmHg)
Time frame: 12 weeks
3 secondary outcomes
Retrobulbar flow velocities as measured with color Doppler imaging (cm/s)
Time frame: 12 weeks
Mean defect of visual field measured with automated perimetry (dB)
Time frame: 12 weeks
Corneal thickness as measured with pachymetry (µm)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing latanoprost 0.005% + timolol 0,5% fixed combination and brimonidine 0,2% + timolol 0,5% fixed combination in people with Retina and Ocular Physiology, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic disc blood flow measured with laser Doppler flowmeter (rel units) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.