CompletedNCT01310777Updated Mar 6, 2014Results posted

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 interventional study of Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Brinzolamide 1% ophthalmic suspension in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-06.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 771
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Open-Angle Glaucoma
Ocular Hypertension

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Keywords

Open-Angle glaucoma
Ocular Hypertension
OAG
OHT

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 771 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

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Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 771 participants (actual)

Study arms

Experimental
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Active comparator
Brinz
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brinzolamide 1% ophthalmic suspension
Active comparator
Brim
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brimonidine tartrate 0.2% ophthalmic solution

Interventions

DrugBrinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
DrugBrinzolamide 1% ophthalmic suspension
Also known as: AZOPT™
DrugBrimonidine tartrate 0.2% ophthalmic solution

What researchers measure

Primary outcomes

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).
Time frame: Baseline (Day 1), Month 3

Results

Posted Mar 6, 2014

Participant flow

Subjects were recruited from 63 investigational centers in the Asia-Pacific region, the European Union, Latin America and Caribbean nations, and the United States.

Participant flow — Overall Study
Milestone	Brinz/Brim	Brinz	Brim
Started	193	192	175
Completed	160	178	145
Not completed	33	14	30
Withdrew: Adverse event	23	1	15
Withdrew: Lost to follow-up	0	4	1
Withdrew: Patient's decision unrelated to ae	1	1	2
Withdrew: Inadequate control of iop	5	7	10
Withdrew: Other	4	1	2

Outcome measures

PrimaryMean 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).

Time frame:: Baseline (Day 1), Month 3
Reported as:: Least squares mean · millimeters of mercury (mmHg)

Mean Diurnal IOP Change From Baseline at Month 3
millimeters of mercury (mmHg)	Brinz/Brim	Brinz	Brim
Mean Diurnal IOP Change From Baseline at Month 3	-7.9 ± 0.22	-6.5 ± 0.23	-6.4 ± 0.24

Adverse events

Collected over Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Brinz/Brim	—	5/193 (2.6%)	44/193 (22.8%)
Brinz	—	2/192 (1%)	12/192 (6.3%)
Brim	—	3/175 (1.7%)	18/175 (10.3%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	Brinz/Brim	Brinz	Brim
Carotid artery occlusionNervous system disorders	0/193	0/192	1/175
ConcussionInjury, poisoning and procedural complications	0/193	0/192	1/175
CystitisInfections and infestations	0/193	0/192	1/175
HeadacheNervous system disorders	0/193	0/192	1/175
Macular degenerationEye disorders	0/193	0/192	1/175
Calculus urethralRenal and urinary disorders	0/193	1/192	0/175
CholecystitisHepatobiliary disorders	0/193	1/192	0/175
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/193	0/192	0/175
CellulitisInfections and infestations	1/193	0/192	0/175
Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/193	0/192	0/175

Most frequent other events

Most frequent other events
Event	Brinz/Brim	Brinz	Brim
Ocular hyperaemiaEye disorders	11/193	3/192	9/175
ConjunctivitisEye disorders	11/193	2/192	2/175
Vision BlurredEye disorders	11/193	1/192	3/175
Eye PainEye disorders	11/193	3/192	0/175
DysgeusiaNervous system disorders	11/193	4/192	2/175
Dry MouthGastrointestinal disorders	7/193	2/192	9/175

Baseline characteristics

This reporting group includes all randomized subjects.

Age, Customized
Age, Customized(participants)	Brinz/Brim	Brinz	Brim	Total
<65 years	91	87	79	257
≥65 years	102	105	96	303

Sex: Female, Male
Sex: Female, Male(Participants)	Brinz/Brim	Brinz	Brim	Total
Female	106	102	102	310
Male	87	90	73	250

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01310777
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Mar 9, 2011
Start date: May 2011
Primary completion: Jan 2013
Completion: Jan 2013
Results posted: Mar 6, 2014
Last update: Mar 6, 2014

Study contacts

James Teague, Sr. Clinical Manager

study director · Alcon Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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