Trial · NCT01297517

Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

NCT01297517, Phase 3, Completed, Alcon Research; results first posted 2013-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%. Trials, record NCT01297517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01297517

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
NCT number: NCT01297517
Status: Completed
Phases: Phase 3
Enrollment: 1,001 participants, actual
Lead sponsor: Alcon Research
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Interventions: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1%, Brimonidine tartrate ophthalmic solution, 0.2%
First posted: 2011-02-16
Last updated: 2013-05-21
Results first posted: 2013-05-13

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Month 3	At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Month 3	Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.	millimeters mercury (mm Hg)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide/Brimonidine	8 am (before study drug instillation)	20.5	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide	8 am (before study drug instillation)	21.6	Standard Error 0.28	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brimonidine	8 am (before study drug instillation)	23.3	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide/Brimonidine	+2 hrs relative to 8 am dosing	17.2	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide	+2 hrs relative to 8 am dosing	20.4	Standard Error 0.28	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brimonidine	+2 hrs relative to 8 am dosing	19.7	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide/Brimonidine	+7 hrs relative to 8 am dosing	18.7	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide	+7 hrs relative to 8 am dosing	20.4	Standard Error 0.28	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brimonidine	+7 hrs relative to 8 am dosing	21.3	Standard Error 0.29	millimeters mercury (mm Hg)
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)	Brinzolamide/Brimonidine	+9 hrs relative to 8 am dosing	17.0	Standard Error 0.29	millimeters mercury (mm Hg)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brinzolamide/Brimonidine	214
Overall Study	STARTED	Brinzolamide	226
Overall Study	STARTED	Brimonidine	220
Overall Study	COMPLETED	Brinzolamide/Brimonidine	187
Overall Study	COMPLETED	Brinzolamide	214
Overall Study	COMPLETED	Brimonidine	193
Overall Study	NOT COMPLETED	Brinzolamide/Brimonidine	27
Overall Study	NOT COMPLETED	Brinzolamide	12
Overall Study	NOT COMPLETED	Brimonidine	27

Source ClinicalTrials.gov

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vision blurred	Eye disorders	Brinzolamide/Brimonidine	14	214
other	Vision blurred	Eye disorders	Brinzolamide	15	226
other	Vision blurred	Eye disorders	Brimonidine	1	220
other	Dysgeusia	Nervous system disorders	Brinzolamide/Brimonidine	8	214
other	Dysgeusia	Nervous system disorders	Brinzolamide	14	226
other	Dysgeusia	Nervous system disorders	Brimonidine	0	220
serious	Cardiac pacemaker insertion	Surgical and medical procedures	Brinzolamide/Brimonidine	1	214
serious	Cardiac pacemaker insertion	Surgical and medical procedures	Brinzolamide	0	226
serious	Cardiac pacemaker insertion	Surgical and medical procedures	Brimonidine	0	220
serious	Vertigo	Ear and labyrinth disorders	Brinzolamide/Brimonidine	1	214

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brinzolamide/Brimonidine
Total, all-cause mortality	Brinzolamide
Total, all-cause mortality	Brimonidine
Total, other adverse events	Brinzolamide/Brimonidine	20	214
Total, other adverse events	Brinzolamide	26	226
Total, other adverse events	Brimonidine	1	220
Total, serious adverse events	Brinzolamide/Brimonidine	2	214
Total, serious adverse events	Brinzolamide	6	226
Total, serious adverse events	Brimonidine	2	220

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23579344	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01297517

GET https://conductscience.org/api/trials/v1/NCT01297517/events?page=2

API reference For AI assistants