Trial · NCT01297920

Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

NCT01297920, Phase 3, Completed, Alcon Research; results first posted 2013-07-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%. Trials, record NCT01297920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01297920

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Trial

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

Title: Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
NCT number: NCT01297920
Status: Completed
Phases: Phase 3
Enrollment: 1,062 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: 2011-02-17
Last updated: 2013-07-04
Results first posted: 2013-07-04

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Month 3	The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Month 3	Intent-to-Treat (ITT): All subjects 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinz/Brim	8 AM (before study drug instillation)	21.1	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinzolamide	8 AM (before study drug instillation)	22.0	Standard Error 0.29	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brimonidine	8 AM (before study drug instillation)	23.2	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinz/Brim	+ 2 hours relative to 8 AM dosing	18.0	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinzolamide	+ 2 hours relative to 8 AM dosing	20.8	Standard Error 0.29	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brimonidine	+ 2 hours relative to 8 AM dosing	19.9	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinz/Brim	+ 7 hours relative to 8 AM dosing	19.5	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinzolamide	+ 7 hours relative to 8 AM dosing	20.7	Standard Error 0.29	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brimonidine	+ 7 hours relative to 8 AM dosing	21.5	Standard Error 0.30	millimeters mercury (mm HG)
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3	Brinz/Brim	+ 9 hours relative to 8 AM dosing	17.2	Standard Error 0.30	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	Brinz/Brim	221
Overall Study	STARTED	Brinzolamide	234
Overall Study	STARTED	Brimonidine	235
Overall Study	COMPLETED	Brinz/Brim	163
Overall Study	COMPLETED	Brinzolamide	207
Overall Study	COMPLETED	Brimonidine	178
Overall Study	NOT COMPLETED	Brinz/Brim	58
Overall Study	NOT COMPLETED	Brinzolamide	27
Overall Study	NOT COMPLETED	Brimonidine	57

Source ClinicalTrials.gov

Adverse events96

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	Conjunctivitis	Eye disorders	Brinz/Brim	16	221
other	Conjunctivitis	Eye disorders	Brinzolamide	0	234
other	Conjunctivitis	Eye disorders	Brimonidine	15	235
other	Vision blurred	Eye disorders	Brinz/Brim	12	221
other	Vision blurred	Eye disorders	Brinzolamide	18	234
other	Vision blurred	Eye disorders	Brimonidine	1	235
other	Eye allergy	Eye disorders	Brinz/Brim	14	221
other	Eye allergy	Eye disorders	Brinzolamide	1	234
other	Eye allergy	Eye disorders	Brimonidine	5	235
other	Eye irritation	Eye disorders	Brinz/Brim	14	221

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brinz/Brim
Total, all-cause mortality	Brinzolamide
Total, all-cause mortality	Brimonidine
Total, other adverse events	Brinz/Brim	53	221
Total, other adverse events	Brinzolamide	35	234
Total, other adverse events	Brimonidine	27	235
Total, serious adverse events	Brinz/Brim	7	221
Total, serious adverse events	Brinzolamide	7	234
Total, serious adverse events	Brimonidine	7	235

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01297920

GET https://conductscience.org/api/trials/v1/NCT01297920/events?page=2

API reference For AI assistants