Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension

Figures & data

Table 1 Demographics and patient characteristics at baseline

Baseline characteristics	Total population (N=358)	Bim/tim subgroup (n=310)a
Gender, n (%)
Female	178 (49.7)	157 (50.6)
Male	180 (50.3)	153 (49.4)
Mean age, years (SD)	63.2 (12.0)	63.5 (11.4)
<61, n (%)	136 (38.0)	116 (37.4)
≥61, n (%)	222 (62.0)	194 (62.6)
Mean baseline IOP, mmHg (SD)
Right eye	19.8 (5.1)	20.0 (5.4)
Left eye	19.9 (5.5)	20.1 (5.5)
Diagnosis, n (%)b
OAGc	324 (90.5)	278 (89.7)
Right eye	300 (83.8)	257 (82.9)
Left eye	302 (84.4)	256 (82.6)
OHT	47 (13.1)	45 (14.5)
Right eye	40 (11.2)	38 (12.3)
Left eye	44 (12.3)	42 (13.5)
Mean time since diagnosis, years (SD)	5.6 (5.8)	4.6 (5.4)
Years since diagnosis, n (%)
<5	207 (57.8)	203 (65.5)
5–10	87 (24.3)	75 (24.2)
≥11	64 (17.9)	32 (10.3)
Previously treated, n (%)	358 (100)	310 (100)
Previous hypotensive therapyd,e
Monotherapy	260 (72.6)	212 (68.4)
Latanoprost	143 (39.9)
Brimonidine	70 (19.6)
Travoprost	54 (15.1)
Bimatoprost	40 (11.2)
Timolol	31 (8.7)
Betaxolol	28 (7.8)
Brinzolamide	17 (4.7)
Carteolol	16 (4.5)
Combination therapy	98 (27.4)	98 (31.6)
Dorzolamide/timolol	108 (30.1)
Latanoprost/timolol	27 (7.5)
Brimonidine/timolol	18 (5.0)
Travoprost/timolol	11 (3.1)

Notes:

a Eight patients received adjunctive therapy in addition to bim/tim.

b The total is >100% because 13 patients had multiple diagnoses.

c OAG included primary OAG (n=217), pseudoexfoliation glaucoma (n=103), and pigmentary glaucoma (n=4).

d Patients with multiple diagnoses could be treated with more than one therapy, or – in this section of the table only – could be counted more than once in one drug category.

e Therapies used by ≥3% of patients are shown.

Abbreviations: Bim/tim, bimatoprost 0.03%/timolol 0.5%; IOP, intraocular pressure; OAG, open-angle glaucoma; OHT, ocular hypertension; SD, standard deviation.

Table 2 Reasons for prescribing PGA/P-containing therapy

Reasonsa	Total population (N=358), n (%)	Bim/tim subgroup (n=310)b, n (%)
Insufficient IOP reduction	275 (76.8)	236 (76.1)
Evidence of disease progression	42 (11.7)	41 (13.2)
Poor tolerability of previous treatment	37 (10.3)	30 (9.7)
Lack of compliance with prior treatment	37 (10.3)	37 (11.9)
Other reason	13 (3.6)	9 (2.9)

Notes:

a Some patients had more than one reason to switch to a PGA/P-containing therapy.

b Eight patients also received adjunctive hypotensive therapy.

Abbreviations: Bim/tim, bimatoprost 0.03%/timolol 0.5%; IOP, intraocular pressure; PGA/P, prostaglandin analog/prostamide.

Figure 1 Mean IOP in the right eye (A) and left eye (B) of the total population and subgroup of patients who received bim/tim during the study.

Notes: Results are expressed as mean ± SD at baseline and 8–12 weeks after switching to a PGA/P-containing therapy (final visit). *P<0.001, compared with baseline (Wilcoxon signed-rank test).
Abbreviations: Bim/tim, bimatoprost 0.03%/timolol 0.5%; IOP, intraocular pressure; PGA/P, prostaglandin analog/prostamide; SD, standard deviation.

Table 3 Hyperemia grading at the final visit, evaluated using a photonumeric bulbar conjunctival hyperemia grading scale

Hyperemia grade	Total populationa (n=318), n (%)		Bim/tim subgroupa (n=271), n (%)
0 (none)	202 (63.5)	302 (95.0)b	155 (57.2)	255 (94.1)b
+0.5 (trace)	68 (21.4)		68 (25.1)
+1 (mild)	32 (10.1)		32 (11.8)
+2 (moderate)	11 (3.5)	16 (5.0)c	11 (4.1)	16 (5.9)c
+3 (severe)	5 (1.6)		5 (1.8)

Notes:

a Data were missing for 40 patients in the total population and 39 patients in the bim/tim subgroup.

b Patients with hyperemia graded ≤+1.

c Patients with hyperemia graded +2–+3.

Abbreviation: Bim/tim, bimatoprost 0.03%/timolol 0.5%.

Table 4 Distribution of patients with conjunctival hyperemia reported as an AE by previous treatment and time since diagnosis

Previous treatment	Time since diagnosis, n (%a/%b)			Totala
	<5 years (n=207)	5–10 years (n=87)	≥11 years (n=64)
Betaxolol (n=28)	0	0	1 (3.6/1.6)	1 (3.6)
Brimonidine (n=70)	2 (2.9/1.0)	0	1 (1.4/1.6)	3 (4.3)
Brimonidine/timolol (n=18)	1 (5.6/0.5)	2 (11.1/2.3)	0	3 (16.7)
Brinzolamide (n=17)	1 (5.9/0.5)	0	0	1 (5.9)
Dorzolamide/timolol (n=105)	7 (6.7/3.4)	1 (1.0/1.1)	1 (1.0/1.6)	9 (8.6)
Latanoprost (n=143)	1 (0.7/0.5)	0	0	1 (0.7)
Latanoprost/timolol (n=27)	2 (7.4/1.0)	0	0	2 (7.4)
Travoprost (n=54)	0	3 (5.6/3.4)	0	3 (5.6)
Totalb	14 (6.8)^c,d	6 (6.9)c	3 (4.7)c	–

Notes:

a Relative to the total number of patients who previously received the indicated treatment.

b Relative to the total number of patients diagnosed <5, 5–10, and ≥11 years prior to study initiation.

c Patients with hyperemia reported as an AE.

d P=0.224, Chi-square test.

Abbreviation: AE, adverse event.

Table 5 Treatment-related AEs reported in >1% of patients

Treatment-related AEs	Total population (N=358), n (%)	Bim/tim subgroup (n=310), n (%)
Conjunctival hyperemia	23 (6.4)	23 (7.4)
Irritation	15 (4.2)	15 (4.8)
Itchy eyes	6 (1.7)	6 (1.9)
Hyperemia	5 (1.4)	5 (1.6)
Allergic reaction	4 (1.1)	4 (1.3)
Stinging sensation	4 (1.1)	4 (1.3)
Serious AEs	0	0

Abbreviations: AE, adverse event; bim/tim, bimatoprost 0.03%/timolol 0.5%.