Open-Angle GlaucomaPhase 3NCT01309204

Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension and Brimonidine tartrate 0.2% ophthalmic solution in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension and Brimonidine tartrate 0.2% ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,184 participants
Where: No sites listed yet
Study dates: May 2011to Jan 2013
Phase: Phase 3
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

Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
Meet qualifying IOP entry criteria.
Able to understand and sign an informed consent form.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Severe central visual field loss.
Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
Chronic, recurrent or severe inflammatory eye disease.
Ocular trauma within the preceding 6 months.

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Ocular infection or inflammation within the preceding 3 months.
Clinically significant or progressive retinal disease.
Other ocular pathology.
Intraocular surgery within the 6 months prior to entry.
Ocular laser surgery within the 3 months prior to entry.
Any abnormality preventing reliable applanation tonometry.
Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Recent use of high-dose (>1 gram daily) salicylate therapy.
Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Read the detailed description

This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, Vehicle, Brinzolamide 1% ophthalmic suspension, Brimonidine tartrate 0.2% ophthalmic solution
Keywords: open-angle glaucoma, ocular hypertension, OAG, OHT
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspensionDrug
VehicleDrug
Inactive ingredients used as a placebo for masking purposes
Brinzolamide 1% ophthalmic suspensionDrug
Also called AZOPT™
Brimonidine tartrate 0.2% ophthalmic solutionDrug

Study groups in NCT01309204
Study group	Role	What they receive
Brinz/Brim	Experimental	Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. Receives: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension; Drug: Vehicle
Brinz+Brim	Active comparator	Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. Receives: Drug: Brinzolamide 1% ophthalmic suspension; Drug: Brimonidine tartrate 0.2% ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Diurnal IOP Change From Baseline at Month 3
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Baseline (Day 1), Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jan 2013

First posted7 Mar 2011 (estimated)
Study startMay 2011
Primary completionJan 2013
Study completionJan 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Open-Angle 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01309204
Sponsor's protocol ID: C-10-041
Other IDs: 2010-024513-31
Status last verified: Mar 2014
First submitted: 3 Mar 2011
Last updated: 7 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gandolfi SA, Lim J, Sanseau AC, Parra Restrepo JC, Hamacher T. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014 Dec;31(12):1213-27. doi: 10.1007/s12325-014-0168-y. Epub 2014 Nov 28.
PubMed 25430900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01309204
Acronym / sponsor ID: C-10-041
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: open-angle glaucoma, ocular hypertension, OAG, OHT
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,184 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 7 Mar 2011 (estimated)
Results: Posted 7 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brinz/Brim	Experimental	Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, Drug: VehicleVehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
Brinz+Brim	Active comparator	Drug: Brinzolamide 1% ophthalmic suspension, Drug: Brimonidine tartrate 0.2% ophthalmic solutionBrimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
Meet qualifying IOP entry criteria.
Able to understand and sign an informed consent form.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (16 listed)

Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Severe central visual field loss.
Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
Chronic, recurrent or severe inflammatory eye disease.

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 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension	Drug	Brinz/Brim
VehicleInactive ingredients used as a placebo for masking purposes	Drug	Brinz/Brim
Brinzolamide 1% ophthalmic suspensionAlso: AZOPT™	Drug	Brinz+Brim
Brimonidine tartrate 0.2% ophthalmic solution	Drug	Brinz+Brim

Primary outcome

Mean Diurnal IOP Change From Baseline at Month 3
Time frame: Baseline (Day 1), Month 3
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Results and safety

Results posted to the registry on 7 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brinz/Brim	452	385
Brinz+Brim	436	361

Primary outcome: Mean Diurnal IOP Change From Baseline at Month 3

Time frame: Baseline (Day 1), Month 3. Least squares mean (Standard Error). Unit: millimeters of mercury (mmHg)

Measure	Brinz/Brim n = 384	Brinz+Brim n = 373
Value	-8.5 (0.16)	-8.3 (0.16)

Population analysed: Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.

Adverse events

Time frame: Adverse events (AE) were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject that was administered a study medication, regardless of causal relationship with the medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brinz/Brim	11 of 452 (2.4%)	0 of 452 (0%)	Not reported
Brinz+Brim	8 of 436 (1.8%)	0 of 436 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25430900Gandolfi SA, Lim J, Sanseau AC, Parra Restrepo JC, Hamacher T. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014 Dec;31(12):1213-27. doi: 10.1007/s12325-014-0168-y. Epub 2014 Nov 28.

Related trials for Open-Angle Glaucoma

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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.

Steve Burmaster, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Apr 2014). 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 Diurnal IOP Change From Baseline at Month 3 (time frame: Baseline (Day 1), Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309204, which also lists 1 linked publication.

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 7 Apr 2014.