Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Figures & data

Figure 1 Participant flow chart.

Note: *Patients receiving incorrect study drug were included in the safety population of the actual drug received and in the ITT population of the intended drug.
Abbreviations: BBFC, brinzolamide/brimonidine fixed combination; IOP, intraocular pressure; ITT, intent-to-treat.

Table 1 Demographics and baseline characteristics

Demographic/baseline characteristic	Total population n = 679	BBFC n = 218	Brinzolamide n = 229	Brimonidine n = 232
Age, years
Mean ± standard deviation	64.9 ± 10.4	65.7 ± 10.3	64.2 ± 10.3	64.9 ± 10.5
<65, n (%)	323 (47.6%)	98 (45.0%)	110 (48.0%)	115 (49.6%)
≥65, n (%)	356 (52.4%)	120 (55.0%)	119 (52.0%)	117 (50.4%)
Race, n (%)
White	529 (77.9%)	174 (79.8%)	179 (78.2%)	176 (75.9%)
Black	130 (19.1%)	36 (16.5%)	42 (18.3%)	52 (22.4%)
Asian	9 (1.3%)	3 (1.4%)	5 (2.2%)	1 (0.4%)
Multiracial	3 (0.4%)	0 (0%)	1 (0.4%)	2 (0.9%)
Other	8 (1.2%)	5 (2.3%)	2 (0.9%)	1 (0.4%)
Gender, n (%)
Male	298 (43.9%)	100 (45.9%)	97 (42.4%)	101 (43.5%)
Female	381 (56.1%)	118 (54.1%)	132 (57.6%)	131 (56.5%)
Diagnosis, n (%)
Ocular hypertension	168 (24.7%)	51 (23.4%)	59 (25.8%)	58 (25.0%)
Open-angle glaucoma	511 (75.3%)	167 (76.6%)	170 (74.2%)	172 (75.0%)

Note: Reprinted with permission from Nguyen QH, McMenemy MG, Realini T, et al. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%. J Ocul Pharmacol Ther. 2013;29:290–297.⁶

Abbreviation: BBFC, brinzolamide-brimonidine fixed combination.

Table 2 Treatment-related adverse events (incidence ≥1%)

Treatment-related adverse event	BBFC n = 221 n (%)	Brinzolamide n = 234 n (%)	Brimonidine n = 235 n (%)
Ocular
Eye irritation	14 (6.3%)	3 (1.3%)	8 (3.4%)
Eye allergy	14 (6.3%)	1 (0.4%)	5 (2.1%)
Conjunctivitis	11 (5.0%)	0 (0%)	14 (6.0%)
Vision blurred	10 (4.5%)	16 (6.8%)	0 (0%)
Conjunctivitis allergic	8 (3.6%)	1 (0.4%)	10 (4.3%)
Eye pruritus	7 (3.2%)	2 (0.9%)	3 (1.3%)
Eye pain	6 (2.7%)	4 (1.7%)	3 (1.3%)
Ocular hyperemia	6 (2.7%)	1 (0.4%)	9 (3.8%)
Conjunctival hyperemia	5 (2.3%)	1 (0.4%)	3 (1.3%)
Dry eye	4 (1.8%)	2 (0.9%)	2 (0.9%)
Lacrimation increased	3 (1.4%)	1 (0.4%)	2 (0.9%)
Conjunctival follicles	1 (0.5%)	0 (0%)	4 (1.7%)
Nonocular
Dysgeusia	9 (4.1%)	24 (10.3%)	1 (0.4%)
Dry mouth	7 (3.2%)	0 (0%)	5 (2.1%)
Fatigue	1 (0.5%)	0 (0%)	4 (1.7%)

Abbreviation: BBFC, brinzolamide-brimonidine fixed combination.

Table 3 Changes in ocular signs from baseline to any visit through month 6

Ocular sign	Changes from baseline through month 6
	BBFC n = 221 n (%)	Brinzolamide n = 232 n (%)	Brimonidine n = 235 n (%)
Cornea	15 (6.8%)	9 (3.9%)	6 (2.6%)
Iris/anterior chamber	2 (0.9%)	2 (0.9%)	1 (0.4%)
Lens	8 (3.6%)	2 (0.9%)	2 (0.9%)
Eyelids/conjunctiva	59 (26.7%)	13 (5.6%)	52 (22.1%)

Abbreviation: BBFC, brinzolamide-brimonidine fixed combination.

Table 4 Changes in fundus parameters from baseline to any visit through month 6

Fundus parameter	Changes from baseline through month 6 visit
	BBFC n = 211 n (%)	Brinzolamide n = 229 n (%)	Brimonidine n = 221 n (%)
Vitreous, n (%)	2 (0.9%)	3 (1.3%)	2 (0.9%)
Retina/macula/choroid, n (%)	6 (2.8%)	1 (0.4%)	2 (0.9%)
Optic nerve, n (%)	4 (1.9%)	7 (3.1%)	3 (1.4%)
Cup/disc ratio, mean ± SD*
Horizontal	−0.002 ± 0.02	0.004 ± 0.03	0.002 ± 0.03
Vertical	−0.002 ± 0.03	0.004 ± 0.05	0.002 ± 0.03

Note:

* Changes in cup/disc ratio were from baseline to exit visit.

Abbreviations: BBFC, brinzolamide-brimonidine fixed combination; SD, standard deviation.

Figure 2 Distribution of systolic and diastolic blood pressure and pulse rate at 10 am: baseline visit versus six-month visit.

Notes: Blood pressure was analyzed using the safety population. *For pulse rate, n = 212.
Abbreviation: BBFC, brinzolamide/brimonidine fixed combination.

NguyenQHMcMenemyMGRealiniTPhase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%J Ocul Pharmacol Ther20132929029723425430

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