Trial Outcomes & Findings for Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes (NCT NCT02512042)

NCT ID: NCT02512042

Last Updated: 2020-03-02

Results Overview

The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

973 participants

Primary outcome timeframe

Day 14 and 42 at 8AM and 10AM

Results posted on

2020-03-02

Participant Flow

The populations for this study included the Randomized Population, Safety Population and Per Protocol Population.

Participant milestones

Participant milestones
Measure	Generic Brinzolamide Ophthalmic Suspension USP 1% Study subjects used one drop in both eyes three times daily for 42 days.	Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) Study subjects used one drop in both eyes three times daily for 42 days.
Overall Study STARTED	495	478
Overall Study COMPLETED	472	453
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Generic Brinzolamide Ophthalmic Suspension USP 1% Study subjects used one drop in both eyes three times daily for 42 days.	Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) Study subjects used one drop in both eyes three times daily for 42 days.
Overall Study Adverse Event	0	4
Overall Study Withdrawal by Subject	6	6
Overall Study Non-compliance with study drug	1	2
Overall Study Lost to Follow-up	5	2
Overall Study Other	11	11

Baseline Characteristics

Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Generic Brinzolamide 1% Ophthalmic Suspension n=495 Participants Study subjects used one drop in both eyes three times daily for 42 days.	Azopt® 1% Ophthalmic Suspension n=478 Participants Study subjects used one drop in both eyes three times daily for 42 days.	Total n=973 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 14.50 • n=5 Participants	53.0 years STANDARD_DEVIATION 14.19 • n=7 Participants	52.9 years STANDARD_DEVIATION 14.34 • n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants	206 Participants n=7 Participants	428 Participants n=5 Participants
Sex: Female, Male Male	273 Participants n=5 Participants	272 Participants n=7 Participants	545 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	431 Participants n=5 Participants	417 Participants n=7 Participants	848 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	48 Participants n=5 Participants	41 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	414 Participants n=5 Participants	402 Participants n=7 Participants	816 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants	61 Participants n=7 Participants	128 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	2 Participants n=7 Participants	2 Participants n=5 Participants
Iris Colour Blue	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Iris Colour Green	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Iris Colour Grey	21 Participants n=5 Participants	31 Participants n=7 Participants	52 Participants n=5 Participants
Iris Colour Hazel	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Iris Colour Brown	282 Participants n=5 Participants	265 Participants n=7 Participants	547 Participants n=5 Participants
Iris Colour Black	152 Participants n=5 Participants	149 Participants n=7 Participants	301 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 and 42 at 8AM and 10AM

Population: Participants in Per Protocol Population who met inclusion/exclusion criteria, instilled a pre-specified proportion of the scheduled doses for the specified duration of the study, who did not miss scheduled applications for more than 3 days, and completed evaluations at Day 14 and Day 42 within the visit window.

Outcome measures

Outcome measures
Measure	Generic Brinzolamide Ophthalmic Suspension USP 1% n=489 Participants Study subjects used one drop in both eyes three times daily for 42 days.	Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) n=475 Participants Study subjects used one drop in both eyes three times daily for 42 days.
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points 8AM Visit Day 14	19.35 mmHg Standard Deviation 2.860	19.75 mmHg Standard Deviation 2.874
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points 8AM Visit Day 42	18.53 mmHg Standard Deviation 2.894	18.66 mmHg Standard Deviation 2.851
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points 10AM Visit Day 14	18.70 mmHg Standard Deviation 2.805	19.18 mmHg Standard Deviation 2.710
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points 10AM Visit Day 42	17.94 mmHg Standard Deviation 2.734	18.16 mmHg Standard Deviation 2.824

Adverse Events

Generic Brinzolamide 1% Ophthalmic Suspension

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Azopt® 1% Ophthalmic Suspension

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, CE Studies

Teva Pharmaceuticals USA, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Generic Brinzolamide 1% Ophthalmic Suspension n=489 participants at risk Study subjects used one drop in both eyes three times daily for 42 days.	Azopt® 1% Ophthalmic Suspension n=475 participants at risk Study subjects used one drop in both eyes three times daily for 42 days.
Cardiac disorders Palpitations	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Cardiac disorders Sinus bradycardia	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Asthenopia	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Blepharospasm	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Cataract nuclear	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Chalazion	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Conjunctival disorder	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Conjunctival haemorrhage	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Conjunctival hyperaemia	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Dry eye	1.0% 5/489 • Number of events 5 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 2/475 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Excessive eye blinking	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye discharge	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye inflammation	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 2/475 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye irritation	4.1% 20/489 • Number of events 21 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	1.5% 7/475 • Number of events 7 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye pain	0.82% 4/489 • Number of events 4 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	1.1% 5/475 • Number of events 5 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye pruritus	0.61% 3/489 • Number of events 4 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eyelid dermatochalasis	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eyelid irritation	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eyelid margin crusting	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.63% 3/475 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Foreign body sensation in eyes	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Keratitis	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Lacrimation increased	0.61% 3/489 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.63% 3/475 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Ocular hyperaemia	1.0% 5/489 • Number of events 6 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.63% 3/475 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Photophobia	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Punctuate keratitis	0.20% 1/489 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Vision blurred	1.2% 6/489 • Number of events 6 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	2.5% 12/475 • Number of events 14 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Visual acuity reduced	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal discomfort	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Diarrhoea	0.41% 2/489 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Dry mouth	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Nausea	0.20% 1/489 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Oral discomfort	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Toothache	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 2/475 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Asthenia	0.20% 1/489 • Number of events 2 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/475 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Face oedema	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Oedema peripheral	0.00% 0/489 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.21% 1/475 • Number of events 1 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Pyrexia	0.61% 3/489 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.	0.63% 3/475 • Number of events 3 • Baseline up to 45 days Adverse events were collected from participants who were randomized and received the study drug.