Open-angle GlaucomaPhase 4NCT02730871

Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

A Phase 4 study testing Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Travoprost 0.004%/timolol 0.5% solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) 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 tartrate 0.2% ophthalmic suspension and Travoprost 0.004%/timolol 0.5% solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 173 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2016to 13 Jul 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 open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.
Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.
Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.
Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.
Willing and able to attend all study visits.

Who cannot join

Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.
Any form of glaucoma other than open-angle glaucoma or ocular hypertension.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease in either eye.
Ocular trauma in either eye within the past 6 months prior to the Screening visit.

Show all 14Show fewer

Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit.
Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.
Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication.
Intraocular surgery in either eye within the past 6 months prior to the Screening visit.
Ocular laser surgery in either eye within the past 3 months prior to the Screening visit.
Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study.
Asthma, history of asthma, or severe chronic obstructive pulmonary disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon for Locations (Europe, Asia, and Latin America)
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)

Read the detailed description

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide/brimonidine vehicle, Travoprost 0.004%/timolol 0.5% solution
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
Also called SIMBRINZA® suspension
Brinzolamide/brimonidine vehicleDrug
Inactive ingredients used as placebo comparator
Travoprost 0.004%/timolol 0.5% solutionDrug
Also called DUOTRAV®
1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase

Study groups in NCT02730871
Study group	Role	What they receive
Simbrinza + Duotrav	Experimental	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Receives: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Drug: Travoprost 0.004%/timolol 0.5% solution
Vehicle + Duotrav	Placebo comparator	Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Receives: Drug: Brinzolamide/brimonidine vehicle; Drug: Travoprost 0.004%/timolol 0.5% solution

What is being measured

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

Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
Measured: Baseline, Week 6

Secondary outcomes (4)

Mean Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses.
Measured: Week 6
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
Measured: Baseline, Week 6
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
Measured: Baseline, Week 6
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
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.

24 Jun 201613 Jul 2018

First posted7 Apr 2016 (estimated)
Study start24 Jun 2016
Primary completion13 Jul 2018
Study completion13 Jul 2018

Why it stopped: Enrollment Challenges

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: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02730871
Sponsor's protocol ID: GLJ576-P001
Other IDs: 2016-000176-20, 2016
Status last verified: May 2019
First submitted: 30 Mar 2016
Last updated: 29 May 2019
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 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)
ClinicalTrials.gov ID: NCT02730871
Acronym / sponsor ID: GLJ576-P001
Conditions: Open-angle Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment Challenges
Enrolment: 173 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 24 Jun 2016 (actual)
Primary completion: 13 Jul 2018 (actual)
Study completion: 13 Jul 2018 (actual)
First posted: 7 Apr 2016 (estimated)
Results: Posted 17 May 2019

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 + Duotrav	Experimental	Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Drug: Travoprost 0.004%/timolol 0.5% solutionBrinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
Vehicle + Duotrav	Placebo comparator	Drug: Brinzolamide/brimonidine vehicle, Drug: Travoprost 0.004%/timolol 0.5% solutionBrinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

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 pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.
Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.
Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.
Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.
Willing and able to attend all study visits.

Key exclusion criteria (14 listed)

Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.
Any form of glaucoma other than open-angle glaucoma or ocular hypertension.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease in either eye.

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 suspensionAlso: SIMBRINZA® suspension	Drug	Simbrinza + Duotrav
Brinzolamide/brimonidine vehicleInactive ingredients used as placebo comparator	Drug	Vehicle + Duotrav
Travoprost 0.004%/timolol 0.5% solutionAlso: DUOTRAV®1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase	Drug	Simbrinza + Duotrav, Vehicle + Duotrav

Primary outcome

Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
Time frame: Baseline, Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

4 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 (09:00, 11:00) at Week 6
Time frame: Baseline, Week 6
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 17 May 2019, 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 + Duotrav	67	61
Vehicle + Duotrav	67	67

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

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

Measure	Simbrinza + Duotrav n = 61	Vehicle + Duotrav n = 67
Value	-4.5 (2.69)	-2.4 (3.01)

Simbrinza + Duotrav vs Vehicle + Duotrav: Mean Difference (Final Values): -2.15 (95% CI -2.8 to -1.5), p <0.001, ANCOVA

Population analysed: Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through study completion, an average of 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simbrinza + Duotrav	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Vehicle + Duotrav	1 of 67 (1.5%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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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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.

Assoc Global Trial Director, TM Ophtha study director

Alcon Research

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 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: stopped early, as of the sponsor's last update on 29 May 2019. 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. 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 17 May 2019). 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 in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 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 NCT02730871.

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 29 May 2019.