Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01722604
• Collaborator: (none)
• Enrollment: 258
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 32.2

Study Details

Study Description

Brief Summary

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Open Angle or Ocular Hypertension	Drug: brinzolamide 1% ophthalmic suspension; Drug: Azopt 1%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Azopt 1% ophthalmic suspension Ophthalmic suspension	Drug: Azopt 1%; Azopt 1%, RLD
Experimental: Brinzolamide 1% ophthalmic suspension ophthalmic suspension	Drug: brinzolamide 1% ophthalmic suspension; brinzolamide 1% ophthalmic suspension

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) at Week 12 [Week 12]

Secondary Outcome Measures

1. Change in Intraocular Pressure (IOP) From Baseline to Week 12 [Baseline, Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and females 18 years of age or older,

• diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

• Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,

• ocular hypertension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	US01	Louisville	Kentucky	United States	40217

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01722604
• Other Study ID Numbers: CD-11-265
• First Posted: Nov 7, 2012
• Last Update Posted: Jun 9, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Ocular Hypertension; Brinzolamide

Study Results

Participant Flow

Arm/Group Title	Brinzolamide 1% Ophthalmic Suspension	Azopt 1% Ophthalmic Suspension
Arm/Group Description	ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Period Title: Overall Study
STARTED	129	129
COMPLETED	123	120
NOT COMPLETED	6	9

Baseline Characteristics

Arm/Group Title	Brinzolamide 1% Ophthalmic Suspension	Azopt 1% Ophthalmic Suspension	Total
Arm/Group Description	ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Ophthalmic suspension Azopt 1%: Azopt 1%, RLD	Total of all reporting groups
Overall Participants	129	129	258
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64.1	65.3	64.6
Sex: Female, Male (Count of Participants)
Female	78 60.5%	81 62.8%	159 61.6%
Male	51 39.5%	48 37.2%	99 38.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%	0 0%	1 0.4%
Asian	2 1.6%	0 0%	2 0.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	29 22.5%	32 24.8%	61 23.6%
White	97 75.2%	97 75.2%	194 75.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) at Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Brinzolamide 1% Ophthalmic Suspension	Azopt 1% Ophthalmic Suspension
Arm/Group Description	ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Measure Participants	122	124
Mean (Standard Deviation) [mmHg]	20.6 (3.21)	20.8 (3.37)

2. Secondary Outcome

Title	Change in Intraocular Pressure (IOP) From Baseline to Week 12
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Brinzolamide 1% Ophthalmic Suspension	Azopt 1% Ophthalmic Suspension
Arm/Group Description	ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension	Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
Measure Participants	122	124
Mean (Standard Deviation) [mmHg]	-5.3 (2.79)	-5.4 (3.27)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Brinzolamide 1% Ophthalmic Suspension		Azopt 1% Ophthalmic Suspension
Arm/Group Description	ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension		Ophthalmic suspension Azopt 1%: Azopt 1%, RLD
All Cause Mortality
	Brinzolamide 1% Ophthalmic Suspension		Azopt 1% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/129 (0%)
Serious Adverse Events
	Brinzolamide 1% Ophthalmic Suspension		Azopt 1% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/129 (1.6%)		3/129 (2.3%)
Cardiac disorders
Atrial fibrillation	0/129 (0%)		1/129 (0.8%)
Coronary artery disease	0/129 (0%)		1/129 (0.8%)
Gastrointestinal disorders
Ileus	1/129 (0.8%)		0/129 (0%)
Small intestinal obstruction	1/129 (0.8%)		0/129 (0%)
Hepatobiliary disorders
Cholelithiasis	0/129 (0%)		1/129 (0.8%)
Infections and infestations
Diverticulitis	0/129 (0%)		1/129 (0.8%)
Pyelonephritis	0/129 (0%)		1/129 (0.8%)
Musculoskeletal and connective tissue disorders
Arthropathy	1/129 (0.8%)		0/129 (0%)
Renal and urinary disorders
Renal failure acute	1/129 (0.8%)		0/129 (0%)
Other (Not Including Serious) Adverse Events
	Brinzolamide 1% Ophthalmic Suspension		Azopt 1% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/129 (7%)		5/129 (3.9%)
General disorders
Instillation site complication	9/129 (7%)		5/129 (3.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact sponsor directly for details.