Open-Angle GlaucomaPhase 4NCT02419508

SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

A Phase 4 study testing Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension and Prostaglandin analogue in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.

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 is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects 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 0.2% tartrate ophthalmic suspension and Prostaglandin analogue
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2015to 27 Feb 2018
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 either open-angle glaucoma or ocular hypertension;
Must sign an informed consent form;
Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
Willing and able to attend all study visits;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

Read the detailed description

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, Brinz/brim vehicle, Prostaglandin analogue
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 0.2% tartrate ophthalmic suspensionDrug
Also called SIMBRINZA® suspension
Brinz/brim vehicleDrug
Inactive ingredients used as a placebo for masking purposes
Prostaglandin analogueDrug
Also called TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)

Study groups in NCT02419508
Study group	Role	What they receive
SIMBRINZA + PGA	Experimental	Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days Receives: Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Drug: Prostaglandin analogue
Vehicle + PGA	Other	Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days Receives: Drug: Brinz/brim vehicle; Drug: Prostaglandin analogue

What is being measured

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

Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6

Secondary outcomes (6)

Mean Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Measured: Week 6
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Mean Change From Baseline in IOP at 11:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Mean Change From Baseline in IOP at 09:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Mean Percentage Change From Baseline at 09:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6

Timeline

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

7 Aug 201527 Feb 2018

First posted17 Apr 2015 (estimated)
Study start7 Aug 2015
Primary completion27 Feb 2018
Study completion27 Feb 2018

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02419508
Sponsor's protocol ID: GLH694-P001
Other IDs: 2015-000736-15, REec-2015-1723, 2015
Status last verified: Nov 2018
First submitted: 14 Apr 2015
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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?

See locations

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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
ClinicalTrials.gov ID: NCT02419508
Acronym / sponsor ID: GLH694-P001
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 7 Aug 2015 (actual)
Primary completion: 27 Feb 2018 (actual)
Study completion: 27 Feb 2018 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Posted 15 Nov 2018

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SIMBRINZA + PGA	Experimental	Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, Drug: Prostaglandin analogueBrinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
Vehicle + PGA	Other	Drug: Brinz/brim vehicle, Drug: Prostaglandin analogueBrinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

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 either open-angle glaucoma or ocular hypertension;
Must sign an informed consent form;
Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
Willing and able to attend all study visits;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (5 listed)

Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
Other protocol-specified exclusion criteria may apply.

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% tartrate ophthalmic suspensionAlso: SIMBRINZA® suspension	Drug	SIMBRINZA + PGA
Brinz/brim vehicleInactive ingredients used as a placebo for masking purposes	Drug	Vehicle + PGA
Prostaglandin analogueAlso: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)	Drug	SIMBRINZA + PGA, Vehicle + PGA

Primary outcome

Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
Time frame: Baseline, Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

6 secondary outcomes

Mean Diurnal IOP at Week 6
Time frame: Week 6
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
Time frame: Baseline, Week 6
Mean Change From Baseline in IOP at 11:00 at Week 6
Time frame: Baseline, Week 6
Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
Time frame: Baseline, Week 6
Mean Change From Baseline in IOP at 09:00 at Week 6
Time frame: Baseline, Week 6
Mean Percentage Change From Baseline at 09:00 at Week 6
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SIMBRINZA + PGA	96	86
Vehicle + PGA	92	88

Primary outcome: Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6

Time frame: Baseline, Week 6. Mean (Standard Deviation). Unit: mmHg

Measure	SIMBRINZA + PGA n = 86	Vehicle + PGA n = 88
Value	-5.6 (2.72)	-2.1 (2.61)

SIMBRINZA + PGA vs Vehicle + PGA: p < 0.001, Mixed Models Analysis

Population analysed: FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through study completion, an average of 6 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SIMBRINZA + PGA	1 of 95 (1.1%)	10 of 95 (10.5%)	0 of 95
Vehicle + PGA	0 of 92 (0%)	1 of 92 (1.1%)	0 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Open-Angle Glaucoma

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Recruiting
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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.

Clinical Manager, Ophtha, GCRA study director

Alcon, a Novartis Company

1 site in 1 country: see every site and its status.

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 5 inclusion and 5 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 15 Nov 2018. 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 15 Nov 2018). 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 (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 (time frame: Baseline, Week 6). 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 NCT02419508.

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 15 Nov 2018.