Trial Outcomes & Findings for Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt (NCT NCT03896633)

NCT ID: NCT03896633

Last Updated: 2023-05-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 637 participants
• Primary outcome timeframe: 6 weeks
• 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	321	316
Overall Study COMPLETED	312	306
Overall Study NOT COMPLETED	9	10

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=321 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=316 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD	Total n=637 Participants Total of all reporting groups
Age, Continuous	65.1 years n=5 Participants	63.8 years n=7 Participants	64.4 years n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	190 Participants n=7 Participants	389 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	126 Participants n=7 Participants	248 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	87 Participants n=5 Participants	81 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) White	220 Participants n=5 Participants	223 Participants n=7 Participants	443 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The Per Protocol Population was utilized for the primary outcome, included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation.

Outcome measures

Measure	Brinzolamide 1% Ophthalmic Suspension n=292 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=296 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Intraocular Pressure (IOP)	20.07 mmHg Standard Deviation 3.269	19.89 mmHg Standard Deviation 3.183

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: The Per Protocol Population was utilized for this outcome; included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation.

Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.

Outcome measures

Measure	Brinzolamide 1% Ophthalmic Suspension n=292 Participants ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=296 Participants Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Change in Intraocular Pressure (IOP)	-4.85 mmHg Standard Deviation 2.792	-4.70 mmHg Standard Deviation 2.861

Adverse Events

Brinzolamide 1% Ophthalmic Suspension

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Azopt 1% Ophthalmic Suspension

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brinzolamide 1% Ophthalmic Suspension n=320 participants at risk ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=318 participants at risk Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Gastrointestinal disorders Abdominal pain upper	0.00% 0/320 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.	0.31% 1/318 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/320 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.	0.31% 1/318 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.

Other adverse events

Measure	Brinzolamide 1% Ophthalmic Suspension n=320 participants at risk ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Azopt 1% Ophthalmic Suspension n=318 participants at risk Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Nervous system disorders Dysgeusia	4.7% 15/320 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.	6.9% 22/318 • 6 weeks One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.

Additional Information

Daniel Donatello

Bausch & Lomb

Phone: 5853385306

Email: Daniel.Donatello@bausch.com

Results disclosure agreements

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

Restriction type: OTHER