Open-Angle GlaucomaPhase 3NCT01310777
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Brinzolamide 1%/brimonidine tartrate 0.2% 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.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components 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% 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
- 771 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.
- 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.
- Ocular infection or ocular inflammation within the preceding 3 months.
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- 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, including severe illness, which would make the subject, 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.
- Concurrent use of glucocorticoid medications administered by any route.
- Other protocol-specified exclusion crtieria may apply.
About this study
Official title: Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components 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 3 study drug groups: Brinz/Brim, Brinz, or Brim.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 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% ophthalmic suspensionDrug
Brinzolamide 1% ophthalmic suspensionDrug
Also called AZOPT™
Brimonidine tartrate 0.2% ophthalmic solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Brinz/Brim | Experimental | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Receives: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension |
| Brinz | Active comparator | Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Receives: Drug: Brinzolamide 1% ophthalmic suspension |
| Brim | Active comparator | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months Receives: 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, + 2 h, and + 7 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.
- First posted9 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.
- 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
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Teague, Sr. Clinical Manager, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310777
- Sponsor's protocol ID
- C-10-040
- Other IDs
- 2010-024512-34
- Status last verified
- Dec 2013
- First submitted
- 7 Mar 2011
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01310777
- Acronym / sponsor ID
- C-10-040
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Open-Angle glaucoma, Ocular Hypertension, OAG, OHT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 771 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
- 9 Mar 2011 (estimated)
- Results
- Posted 6 Mar 2014
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 evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.
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 3 study drug groups: Brinz/Brim, Brinz, or Brim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, 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 2 times a day for 6 months |
| Brinz | Active comparator | Drug: Brinzolamide 1% ophthalmic suspensionBrinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months |
| Brim | Active comparator | Drug: Brimonidine tartrate 0.2% ophthalmic solutionBrimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times 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.
- 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.
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 1% ophthalmic suspensionAlso: AZOPT™ | Drug | Brinz |
| Brimonidine tartrate 0.2% ophthalmic solution | Drug | 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, + 2 h, and + 7 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Sr. Clinical Manager study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brinzolamide 1%/brimonidine tartrate 0.2% 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.
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 6 Mar 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 6 Mar 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?
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 6 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.