Open-Angle GlaucomaPhase 3NCT01297920

Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

A Phase 3 study testing Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1% and Brimonidine tartrate ophthalmic solution, 0.2% 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 a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1% and Brimonidine tartrate ophthalmic solution, 0.2%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,062 participants
Where: No sites listed yet
Study dates: Mar 2011to Jun 2012
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

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
Chronic, recurrent, or severe inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.

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Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
Ocular surgery within the preceding 6 months.
Ocular laser surgery within the preceding 3 months.
Any abnormality preventing reliable applanation tonometry.
Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1%, Brimonidine tartrate ophthalmic solution, 0.2%
Keywords: Open-Angle Glaucoma, Ocular Hypertension, Brinzolamide, Brimonidine, Intraocular pressure
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% ophthalmic suspensionDrug
Brinzolamide ophthalmic suspension, 1%Drug
Brimonidine tartrate ophthalmic solution, 0.2%Drug

Study groups in NCT01297920
Study group	Role	What they receive
Brinz/Brim	Experimental	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months Receives: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Brinzolamide	Active comparator	Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months Receives: Drug: Brinzolamide ophthalmic suspension, 1%
Brimonidine	Active comparator	Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months Receives: Drug: Brimonidine tartrate ophthalmic solution, 0.2%

What is being measured

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

Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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: Month 3

Timeline

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

Mar 2011Jun 2012

First posted17 Feb 2011 (estimated)
Study startMar 2011
Primary completionJun 2012
Study completionJun 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 Open-Angle GlaucomaStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,062 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01297920
Sponsor's protocol ID: C-10-039
Status last verified: May 2013
First submitted: 15 Feb 2011
Last updated: 4 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
ClinicalTrials.gov ID: NCT01297920
Acronym / sponsor ID: C-10-039
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Open-Angle Glaucoma, Ocular Hypertension, Brinzolamide, Brimonidine, Intraocular pressure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,062 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Feb 2011 (estimated)
Results: Posted 4 Jul 2013

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Brinz/Brim	Experimental	Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspensionBrinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
Brinzolamide	Active comparator	Drug: Brinzolamide ophthalmic suspension, 1%Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
Brimonidine	Active comparator	Drug: Brimonidine tartrate ophthalmic solution, 0.2%Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months

Who may qualify

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

Key inclusion criteria (3 listed)

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (14 listed)

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
Chronic, recurrent, or severe inflammatory eye disease.
Ocular trauma within the preceding 6 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
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension	Drug	Brinz/Brim
Brinzolamide ophthalmic suspension, 1%	Drug	Brinzolamide
Brimonidine tartrate ophthalmic solution, 0.2%	Drug	Brimonidine

Primary outcome

Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
Time frame: Month 3
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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 4 Jul 2013, 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	221	163
Brinzolamide	234	207
Brimonidine	235	178

Primary outcome: Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3

Time frame: Month 3. Least squares mean (Standard Error). Unit: millimeters mercury (mm HG)

Measure	Brinz/Brim n = 196	Brinzolamide n = 216	Brimonidine n = 203
8 AM (before study drug instillation)	21.1 (0.30)	22.0 (0.29)	23.2 (0.30)
+ 2 hours relative to 8 AM dosing	18.0 (0.30)	20.8 (0.29)	19.9 (0.30)
+ 7 hours relative to 8 AM dosing	19.5 (0.30)	20.7 (0.29)	21.5 (0.30)
+ 9 hours relative to 8 AM dosing	17.2 (0.30)	20.4 (0.29)	18.9 (0.30)

Population analysed: Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.

Adverse events

Time frame: Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brinz/Brim	7 of 221 (3.2%)	53 of 221 (24%)	Not reported
Brinzolamide	7 of 234 (3%)	35 of 234 (15%)	Not reported
Brimonidine	7 of 235 (3%)	27 of 235 (11.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
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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.

James Teague, BS, Sr. Clinical Manager 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 3 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 4 Jul 2013. 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 4 Jul 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3 (time frame: 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 NCT01297920.

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 4 Jul 2013.