Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost

Figures & data

Table 1 Demographics and clinical characteristics of patients at baseline

	Fixed brimonidine-timolol and latanoprost (n = 102)	Timolol and latanoprost (n = 102)	Between-group P value
Mean (SD) age, years	63.4 (11.3)	64.8 (10.8)	0.813
Sex, n (%)			0.123
Male	45 (44.1%)	57 (55.9%)
Female	57 (55.9%)	45 (44.1%)
Race/ethnicity, n (%)			0.477
Black	26 (25.5%)	24 (23.5%)
White	57 (55.9%)	63 (61.8%)
Hispanic	17 (16.7%)	15 (14.7%)
Asian	1 (1.0%)	0 (0.0%)
Other	1 (1.0%)	0 (0.0%)

Abbreviation: SD, standard deviation.

Figure 1 Study design and patient flow through the study.

Abbreviation: IOP, intraocular pressure.

Figure 2 Mean change from latanoprost-treated baseline intraocular pressure at each time point after addition of fixed-combination brimonidine or timolol. Error bars, standard error of the mean.

Abbreviation: IOP, intraocular pressure.

Table 2 Mean IOP at each time point and visit

	IOP, mmHg, mean (SD)		Between-group P value
	Fixed brimonidine-timolol and latanoprost (n = 94–98)	Timolol and latanoprost (n = 94–97)
Baseline on latanoprost
8 am	23.7 (2.2)	23.5 (2.4)	0.534
10 am	23.4 (2.3)	23.0 (1.8)	0.229
Week 6
8 am	17.3 (2.9)	17.8 (3.2)	0.178
10 am	15.9 (3.1)	16.7 (2.8)	0.021
Week 12
8 am	17.0 (2.6)	17.7 (2.6)	0.069
10 am	15.1 (2.6)	16.9 (2.5)	<0.001

Abbreviations: SD, standard deviation; IOP, intraocular pressure.

Figure 3 Percentage of patients achieving specified intraocular pressure levels at both the 8 am and 10 am measurements at week 12.

Abbreviation: IOP, intraocular pressure.

Table 3 Percentage of patients with at least a 20%, 25%, 30%, or 35% reduction in IOP from latanoprost baseline at both the 8 am and 10 am time points at week 12

	Patients, n (%)		Between-group P value
	Fixed brimonidine-timolol and latanoprost (n = 94)	Timolol and latanoprost (n = 94)
≥20% reduction in IOP from latanoprost baseline	68 (72.3%)	54 (57.5%)	0.047
≥25% reduction in IOP from latanoprost baseline	55 (58.5%)	40 (42.6%)	0.041
≥30% reduction in IOP from latanoprost baseline	44 (46.8%)	21 (22.3%)	<0.001
≥35% reduction in IOP from latanoprost baseline	23 (24.5%)	8 (8.5%)	0.005

Table 4 Summary of adverse events

	Incidence, n (%)		Between-group P value
	Fixed brimonidine-timolol and latanoprost (n = 102)	Timolol and latanoprost (n = 102)
Any adverse event	15 (14.7%)	13 (12.7%)	0.839
Treatment-related adverse event	10 (9.8%)	4 (3.9%)	0.164
Ocular adverse event	9 (8.8%)	7 (6.9%)	0.796
Treatment-related ocular adverse event	8 (7.8%)	4 (3.9%)	0.373
Serious adverse event	0 (0.0%)	1 (1.0%)a	>0.999

a Notes: Acute exacerbation of chronic obstructive pulmonary disease and bacterial bronchitis.

Table 5 Treatment-related adverse events

	Events (n)a
	Fixed brimonidine-timolol and latanoprost (n = 102)	Timolol and latanoprost (n = 102)
Superficial punctate keratitis	1	3
Itching	3	0
Redness	2	1
Allergic conjunctivitis	2	0
Contact dermatitis	2	0
Eye swelling	1	1
Allergy to study medication	1	0
Crusting	1	0
Discomfort	0	1
Dizziness/lightheadedness	1	0
Drowsiness	1	0
Fatigue	1	0
High intraocular pressure	1	0
Low heart rate	1	0
Ocular burning	0	1

a Notes: Multiple treatment-related adverse events were reported in individual patients.

Figure 4 Percentage of patients with at least a one grade increase from latanoprost-treated baseline in severity scores on biomicroscopy at week 12.