Ocular HypertensionPhase 4NCT01937312
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
A Phase 4 study testing Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension and Prostaglandin analogue in people with Ocular Hypertension and Open Angle Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension and Prostaglandin analogue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- 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
- Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
- Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
- Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
- Able to understand and sign Informed Consent Document;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
- Any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Severe central visual field loss;
- Chronic, recurrent, or severe inflammatory eye disease;
- Ocular trauma within the past 6 months;
- Ocular infection or ocular inflammation within the past 3 months;
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- Best-corrected visual acuity score worse than approximately 20/80 Snellen;
- Eye surgery within the past 6 months;
- Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
- Use of any additional topical or systemic ocular hypertensive medication during the study;
- Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
Read the detailed description
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, Vehicle, Prostaglandin analogue
- Keywords
- glaucoma, prostaglandin analogue, brinzolamide, brimonidine
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspensionDrug
Also called SIMBRINZA® Suspension
VehicleDrug
Inactive ingredients used as a placebo comparator
Prostaglandin analogueDrug
Also called TRAVATAN Z®, LUMIGAN®, XALATAN®
| Study group | Role | What they receive |
|---|---|---|
| SIMBRINZA | Experimental | Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks Receives: Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Drug: Prostaglandin analogue |
| Vehicle | Placebo comparator | Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks Receives: Drug: Vehicle; Drug: Prostaglandin analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Diurnal Intraocular Pressure (IOP) at Week 6
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Week 6
Secondary outcomes (3)
Mean Diurnal IOP Change From Baseline to Week 6
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Measured: Baseline, Week 6
Mean Diurnal IOP Percentage Change From Baseline to Week 6
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
Measured: Baseline, Week 6
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Ocular HypertensionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Burmaster, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937312
- Sponsor's protocol ID
- M-13-020
- Status last verified
- Jul 2015
- First submitted
- 4 Sep 2013
- Last updated
- 28 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
- ClinicalTrials.gov ID
- NCT01937312
- Acronym / sponsor ID
- M-13-020
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- glaucoma, prostaglandin analogue, brinzolamide, brimonidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 8 Jun 2015
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 is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
Detailed description
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIMBRINZA | Experimental | Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, Drug: Prostaglandin analogueBrinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks |
| Vehicle | Placebo comparator | Drug: Vehicle, Drug: Prostaglandin analogueInactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
- Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
- Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
- Able to understand and sign Informed Consent Document;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (12 listed)
- Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
- Any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Severe central visual field loss;
- Chronic, recurrent, or severe inflammatory eye disease;
- Ocular trauma within the past 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 0.2% ophthalmic suspensionAlso: SIMBRINZA® Suspension | Drug | SIMBRINZA |
| VehicleInactive ingredients used as a placebo comparator | Drug | Vehicle |
| Prostaglandin analogueAlso: TRAVATAN Z®, LUMIGAN®, XALATAN® | Drug | SIMBRINZA, Vehicle |
Primary outcome
Mean Diurnal Intraocular Pressure (IOP) at Week 6
Time frame: Week 6
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
3 secondary outcomes
Mean Diurnal IOP Change From Baseline to Week 6
Time frame: Baseline, Week 6
Mean Diurnal IOP Percentage Change From Baseline to Week 6
Time frame: Baseline, Week 6
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- 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.
Steve Burmaster, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension and Prostaglandin analogue in people with Ocular Hypertension and Open Angle Glaucoma, 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 5 inclusion and 12 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 28 Jul 2015. 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. Some participants in this study may receive a placebo. 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 8 Jun 2015). 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 Intraocular Pressure (IOP) at Week 6 (time frame: Week 6). 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 28 Jul 2015.