GlaucomaPhase 4NCT00800540
Circadian Ocular Perfusion Pressure and Ocular Blood Flow
A Phase 4 study testing Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension and Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution in people with Glaucoma, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension and Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Sign Informed Consent.
- Diagnosis of open-angle glaucoma in at least one eye.
- Requires more than one IOP-lowering medication.
- IOP measurements at Screening, Safety, and Eligibility/Period 1 Baseline Visits as specified in protocol.
- Able to discontinue all IOP-lowering medication prior to Eligibility Visit and for 4 weeks between treatment periods.
- Willing to complete all required study visits.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Female of child-bearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Severe central visual field loss in either eye.
- Previous glaucoma surgery in the study eye.
- Intraocular surgery in the study eye within 3 months prior to the Screening Visit.
- Wears contact lenses.
- Allergy/hypersensitivity to study medication.
Show all 14Show fewer
- Cannot safely discontinue use of glucocorticoid medication.
- Uses medication that could affect IOP or blood pressure.
- Recent use of high-dose aspirin.
- Bronchial asthma or severe chronic obstructive pulmonary disease.
- Diabetic retinopathy.
- Any abnormality preventing reliable tonometry.
- Any severe illness or condition unsuitable for the study, in the opinion of the investigator.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center at 1-888-451-3937 For Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma
The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.
- Conditions
- Glaucoma
- Being tested
- Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension, Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
- Keywords
- glaucoma, ocular perfusion pressure, ocular blood flow, open angle glaucoma requiring more than one IOP-lowering medication
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspensionDrug
Also called AZARGA™
Fixed combination ophthalmic suspension
Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solutionDrug
Also called COMBIGAN®
Fixed combination ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| AZARGA/COMBIGAN | Other | AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. Receives: Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension; Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution |
| COMBIGAN/AZARGA | Other | COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. Receives: Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension; Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Week 0, Week 6 (period-based)
Secondary outcomes (11)
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Systolic Blood Pressure at Week 6
Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Measured: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Measured: Week 0, Week 6 (period-based)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800540
- Sponsor's protocol ID
- C-07-16
- Other IDs
- 2007-005936-99
- Status last verified
- Mar 2013
- First submitted
- 1 Dec 2008
- Last updated
- 22 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00800540
- Acronym / sponsor ID
- C-07-16
- Conditions
- Glaucoma
- Keywords
- glaucoma, ocular perfusion pressure, ocular blood flow, open angle glaucoma requiring more than one IOP-lowering medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Posted 22 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZARGA/COMBIGAN | Other | Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension, Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solutionAZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. |
| COMBIGAN/AZARGA | Other | Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension, Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solutionCOMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sign Informed Consent.
- Diagnosis of open-angle glaucoma in at least one eye.
- Requires more than one IOP-lowering medication.
- IOP measurements at Screening, Safety, and Eligibility/Period 1 Baseline Visits as specified in protocol.
- Able to discontinue all IOP-lowering medication prior to Eligibility Visit and for 4 weeks between treatment periods.
Key exclusion criteria (14 listed)
- Female of child-bearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Severe central visual field loss in either eye.
- Previous glaucoma surgery in the study eye.
- Intraocular surgery in the study eye within 3 months prior to the Screening Visit.
- Wears contact lenses.
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 |
|---|---|---|
| Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspensionAlso: AZARGA™Fixed combination ophthalmic suspension | Drug | AZARGA/COMBIGAN, COMBIGAN/AZARGA |
| Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solutionAlso: COMBIGAN®Fixed combination ophthalmic solution | Drug | AZARGA/COMBIGAN, COMBIGAN/AZARGA |
Primary outcome
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
Time frame: Week 0, Week 6 (period-based)
Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
11 secondary outcomes
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Systolic Blood Pressure at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
Time frame: Week 0, Week 6 (period-based)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension and Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution in people with Glaucoma, run by Alcon Research at 1 site in United States.
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 7 inclusion and 14 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 22 Mar 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6 (time frame: Week 0, Week 6 (period-based)). 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 22 Mar 2013.