Open-Angle GlaucomaPhase 4NCT01978600

Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

A Phase 4 study testing Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension and Timolol Maleate 0.5% 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 is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension. 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% ophthalmic suspension and Timolol Maleate 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: No sites listed yet
Study dates: Oct 2013to Mar 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

Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
Must sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Ocular trauma or ocular surgery within the past 6 months.
Ocular infection or ocular inflammation within the past 3 months.
Clinically significant or progressive retinal disease.

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Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Any medical condition that would preclude the safe administration of a topical beta-blocker.
Cannot safely discontinue all glucocorticoids administered by any route.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Read the detailed description

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, Timolol Maleate 0.5%
Keywords: Open-Angle Glaucoma, Ocular Hypertension, Simbrinza™, 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 0.2% ophthalmic suspensionDrug
Also called SIMBRINZA™
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Timolol Maleate 0.5%Drug
Also called TIMOPTIC™, TIMOPTIC-XE™, BETIMOL™, ISTALOL™
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Study groups in NCT01978600
Study group	Role	What they receive
SIMBRINZA™	Experimental	Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks Receives: Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
Timolol Maleate 0.5%	Active comparator	Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks Receives: Drug: Timolol Maleate 0.5%

What is being measured

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

Mean Nocturnal IOP at Week 4
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). 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: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

Secondary outcomes (2)

Mean Diurnal IOP at Week 4
Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). 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: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
Mean 24-hour IOP at Week 4
24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). 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: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

Timeline

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

Oct 2013Mar 2014

First posted7 Nov 2013 (estimated)
Study startOct 2013
Primary completionMar 2014
Study completionMar 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 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01978600
Sponsor's protocol ID: M-13-037
Status last verified: Mar 2015
First submitted: 30 Oct 2013
Last updated: 13 Apr 2015
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

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy
ClinicalTrials.gov ID: NCT01978600
Acronym / sponsor ID: M-13-037
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Open-Angle Glaucoma, Ocular Hypertension, Simbrinza™, Intraocular Pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 7 Nov 2013 (estimated)
Results: Posted 13 Apr 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 evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Detailed description

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SIMBRINZA™	Experimental	Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspensionBrinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
Timolol Maleate 0.5%	Active comparator	Drug: Timolol Maleate 0.5%Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks

Who may qualify

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

Key inclusion criteria (4 listed)

Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
Must sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (11 listed)

Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Ocular trauma or ocular surgery within the past 6 months.
Ocular infection or ocular inflammation within the past 3 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™Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.	Drug	SIMBRINZA™
Timolol Maleate 0.5%Also: TIMOPTIC™, TIMOPTIC-XE™, BETIMOL™, ISTALOL™Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.	Drug	Timolol Maleate 0.5%

Primary outcome

Mean Nocturnal IOP at Week 4
Time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). 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).

2 secondary outcomes

Mean Diurnal IOP at Week 4
Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
Mean 24-hour IOP at Week 4
Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

Results and safety

Results posted to the registry on 13 Apr 2015, 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	44	44
Timolol	42	42

Primary outcome: Mean Nocturnal IOP at Week 4

Time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM. Mean (Standard Deviation). Unit: mmHg

Measure	Simbrinza n = 44	Timolol n = 42
Baseline (Day 0)	24.2 (4.01)	23.6 (3.31)
Week 4	18.6 (3.61)	18.9 (2.93)

Population analysed: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (28 Oct 2013 - 03 Mar 2014). Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simbrinza	0 of 44 (0%)	0 of 44 (0%)	Not reported
Timolol	0 of 42 (0%)	0 of 42 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.

Danyel Carr, MS 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 Timolol Maleate 0.5% 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 11 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 13 Apr 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. 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 13 Apr 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 Nocturnal IOP at Week 4 (time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM). 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 NCT01978600.

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 13 Apr 2015.