Trial Outcomes & Findings for A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT05022004)
NCT ID: NCT05022004
Last Updated: 2024-01-18
Results Overview
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
599 participants
Primary outcome timeframe
Baseline, Week 2 & Week 6
Results posted on
2024-01-18
Participant Flow
Participant milestones
| Measure |
BRIN-20-01
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
300
|
|
Overall Study
COMPLETED
|
287
|
289
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
BRIN-20-01
n=297 Participants
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
n=300 Participants
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Total
n=597 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
99 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
204 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
392 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: Baseline, Week 2 & Week 6The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Outcome measures
| Measure |
BRIN-20-01
n=273 Participants
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
n=271 Participants
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
|---|---|---|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Baseline- Right Eye 08:00
|
24.87 mmHg
Standard Deviation 2.378
|
25.12 mmHg
Standard Deviation 2.358
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Baseline - Left Eye 10:00
|
24.54 mmHg
Standard Deviation 2.307
|
24.83 mmHg
Standard Deviation 2.389
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Baeline - Right Eye 10:00
|
24.52 mmHg
Standard Deviation 2.423
|
24.90 mmHg
Standard Deviation 2.365
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Baseline- Left Eye 08:00
|
24.92 mmHg
Standard Deviation 2.290
|
25.06 mmHg
Standard Deviation 2.363
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 2 - Left Eye 08:00
|
19.87 mmHg
Standard Deviation 3.436
|
19.56 mmHg
Standard Deviation 3.642
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 2 - Right Eye 08:00
|
19.81 mmHg
Standard Deviation 3.400
|
19.62 mmHg
Standard Deviation 3.423
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 2 - Left Eye 10:00
|
18.87 mmHg
Standard Deviation 3.544
|
18.39 mmHg
Standard Deviation 3.760
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 2 - Right Eye 10:00
|
18.69 mmHg
Standard Deviation 3.572
|
18.47 mmHg
Standard Deviation 3.468
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 6 - Left Eye 08:00
|
18.86 mmHg
Standard Deviation 3.162
|
18.91 mmHg
Standard Deviation 3.333
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 6 - Right Eye 08:00
|
18.87 mmHg
Standard Deviation 3.067
|
18.99 mmHg
Standard Deviation 3.123
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 6 - Left Eye 10:00
|
17.76 mmHg
Standard Deviation 3.252
|
17.73 mmHg
Standard Deviation 3.418
|
|
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Week 6 - Right Eye 10:00
|
17.71 mmHg
Standard Deviation 3.190
|
17.70 mmHg
Standard Deviation 3.162
|
SECONDARY outcome
Timeframe: approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visitsOutcome measures
| Measure |
BRIN-20-01
n=273 Participants
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
n=271 Participants
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
|---|---|---|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 2 - Right Eye 10:00
|
-5.82 mmHg
Standard Deviation 3.484
|
-6.43 mmHg
Standard Deviation 3.630
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 6- Left Eye 08:00
|
-5.68 mmHg
Standard Deviation 3.290
|
-5.92 mmHg
Standard Deviation 3.577
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 6- Right Eye 08:00
|
-5.64 mmHg
Standard Deviation 3.107
|
-5.91 mmHg
Standard Deviation 3.468
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 2- Left Eye 08:00
|
-4.67 mmHg
Standard Deviation 3.441
|
-5.27 mmHg
Standard Deviation 3.617
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 2- Right Eye 08:00
|
-4.71 mmHg
Standard Deviation 3.286
|
-5.28 mmHg
Standard Deviation 3.531
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 2- Left Eye 10:00
|
-5.68 mmHg
Standard Deviation 3.475
|
-6.44 mmHg
Standard Deviation 3.717
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 6 - Left Eye 10:00
|
-6.78 mmHg
Standard Deviation 3.329
|
-7.10 mmHg
Standard Deviation 3.614
|
|
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Week 6 - Right Eye 10:00
|
-6.81 mmHg
Standard Deviation 3.239
|
-7.20 mmHg
Standard Deviation 3.500
|
Adverse Events
BRIN-20-01
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Azopt®
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BRIN-20-01
n=297 participants at risk
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
n=300 participants at risk
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
|---|---|---|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
Other adverse events
| Measure |
BRIN-20-01
n=297 participants at risk
Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
Azopt®
n=300 participants at risk
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Abnormal Sensation in Eye
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Blepharitis
|
0.34%
1/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Eye disorders
Cataract
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Conjunctival Hyperemia
|
1.0%
3/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Conjunctival Oedema
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Dry Eye
|
0.67%
2/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Eye Irritation
|
1.0%
3/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Eye Pain
|
0.00%
0/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Eye Pruritus
|
0.67%
2/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
1.3%
4/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Keratitis
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Lacrimation Increased
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Ocular Hyperemia
|
1.0%
3/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Eye disorders
Swelling of Eyelid
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Eye disorders
Vision Blurred
|
2.7%
8/297 • 7 Weeks
|
1.3%
4/300 • 7 Weeks
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Eye disorders
Visual Impairment
|
0.67%
2/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Gastrointestinal disorders
Toothache
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Asthenia
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Instillation Site Dryness
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Instillation Site Pain
|
0.67%
2/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Instillation Site Pruritus
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Instillation Site Reaction
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Malaise
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
General disorders
Pyrexia
|
0.34%
1/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Infections and infestations
Conjunctivitis
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.34%
1/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Investigations
Blood Pressure Increased
|
0.67%
2/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Nervous system disorders
Dizziness
|
0.34%
1/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Nervous system disorders
Dysgeusia
|
2.0%
6/297 • 7 Weeks
|
2.7%
8/300 • 7 Weeks
|
|
Nervous system disorders
Headache
|
1.0%
3/297 • 7 Weeks
|
1.0%
3/300 • 7 Weeks
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
2/297 • 7 Weeks
|
1.0%
3/300 • 7 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
1/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/297 • 7 Weeks
|
0.33%
1/300 • 7 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.34%
1/297 • 7 Weeks
|
0.00%
0/300 • 7 Weeks
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/297 • 7 Weeks
|
0.67%
2/300 • 7 Weeks
|
Additional Information
Head-Clinical Development
Sun Pharmaceutical Industries Limited
Phone: 2266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has exclusive rights, including the right of authorship, to all publications concerning Study data and findings. The Institution, the Investigator, and the Co-Investigators are contractually bound not to make any publications, public statements, oral presentations concerning the Study data and findings. The Sponsor shall have the sole right to review, use, publish, and disclose any data, information, or results developed without limitation.
- Publication restrictions are in place
Restriction type: OTHER