Trial Outcomes & Findings for Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt (NCT NCT01722604)

NCT ID: NCT01722604

Last Updated: 2023-05-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 258 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2023-05-09

Participant Flow

Participant milestones

Measure	Brinzolamide 1% Ophthalmic Suspension ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Overall Study STARTED	129	129
Overall Study COMPLETED	123	120
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Baseline characteristics by cohort

Measure	Brinzolamide 1% Ophthalmic Suspension n=129 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=129 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD	Total n=258 Participants Total of all reporting groups
Age, Continuous	64.1 years n=93 Participants	65.3 years n=4 Participants	64.6 years n=27 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	81 Participants n=4 Participants	159 Participants n=27 Participants
Sex: Female, Male Male	51 Participants n=93 Participants	48 Participants n=4 Participants	99 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	29 Participants n=93 Participants	32 Participants n=4 Participants	61 Participants n=27 Participants
Race (NIH/OMB) White	97 Participants n=93 Participants	97 Participants n=4 Participants	194 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.

Outcome measures

Measure	Brinzolamide 1% Ophthalmic Suspension n=122 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=124 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Intraocular Pressure (IOP) at Week 12	20.6 mmHg Standard Deviation 3.21	20.8 mmHg Standard Deviation 3.37

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.

Outcome measures

Measure	Brinzolamide 1% Ophthalmic Suspension n=122 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=124 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Change in Intraocular Pressure (IOP) From Baseline to Week 12	-5.3 mmHg Standard Deviation 2.79	-5.4 mmHg Standard Deviation 3.27

Adverse Events

Brinzolamide 1% Ophthalmic Suspension

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Azopt 1% Ophthalmic Suspension

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brinzolamide 1% Ophthalmic Suspension n=129 participants at risk ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=129 participants at risk Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Cardiac disorders Atrial fibrillation	0.00% 0/129 • 12 weeks	0.78% 1/129 • 12 weeks
Cardiac disorders Coronary artery disease	0.00% 0/129 • 12 weeks	0.78% 1/129 • 12 weeks
Gastrointestinal disorders Ileus	0.78% 1/129 • 12 weeks	0.00% 0/129 • 12 weeks
Gastrointestinal disorders Small intestinal obstruction	0.78% 1/129 • 12 weeks	0.00% 0/129 • 12 weeks
Hepatobiliary disorders Cholelithiasis	0.00% 0/129 • 12 weeks	0.78% 1/129 • 12 weeks
Infections and infestations Diverticulitis	0.00% 0/129 • 12 weeks	0.78% 1/129 • 12 weeks
Infections and infestations Pyelonephritis	0.00% 0/129 • 12 weeks	0.78% 1/129 • 12 weeks
Musculoskeletal and connective tissue disorders Arthropathy	0.78% 1/129 • 12 weeks	0.00% 0/129 • 12 weeks
Renal and urinary disorders Renal failure acute	0.78% 1/129 • 12 weeks	0.00% 0/129 • 12 weeks

Other adverse events

Measure	Brinzolamide 1% Ophthalmic Suspension n=129 participants at risk ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=129 participants at risk Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
General disorders Instillation site complication	7.0% 9/129 • 12 weeks	3.9% 5/129 • 12 weeks

Additional Information

Daniel Donatello

Bausch & Lomb

Phone: (585) 338-5306

Email: Daniel.Donatello@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER