An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan^® RC Early Analysis Review (CLEAR) trial

Figures & data

Table 1 Switch-subject disposition

Prior intraocular pressure (IOP)-lowering therapy	Baseline n	Week 6 n (discontinued)	Week 12 n (discontinued)
Adrenergic agonists	5	4 (1)	4 (1)
• Alphagan^®	1	1 (0)	1 (0)
• Alphagan^® P	3	2 (1)	2 (1)
• Generic brimonidine tartrate	1	1 (0)	1 (0)
Selective beta-adrenergic receptor blockers	3	2 (1)	2 (1)
• Betoptic^®	2	2 (0)	2 (0)
• Generic betaxolol hydrochloride	1	0 (1)	0 (1)
Nonselective beta-adrenergic receptor blockers	40	37 (3)	35 (5)
• Betagan^®	1	1 (0)	1 (0)
• Generic levobunolol hydrochloride	3	3 (0)	3 (0)
• Generic timolol maleate	10	8 (2)	6 (4)
• Timoptic^®	23	22 (1)	22 (1)
• Timoptic XE^® 0.5%	3	3 (0)	3 (0)
Carbonic anhydrase inhibitors	6	6 (0)	6 (0)
• Azopt^®	4	4 (0)	4 (0)
• Trusopt^®	2	2 (0)	2 (0)
Prostaglandin analogs and prostamides	228	216 (12)	202 (26)
• Lumigan^® 0.03%	63	58 (5)	53 (10)
• Travatan^®	16	16 (0)	16 (0)
• Travatan Z^®	36	36 (0)	35 (1)
• Xalatan^®	113	106 (7)	98 (15)
Non-prostaglandin analog combinations	29	27 (2)	27 (2)
• Azarga^®	1	0 (1)	0 (1)
• Combigan^®	15	14 (1)	14 (1)
• Cosopt^®	13	13 (0)	13 (0)
Prostaglandin analog combinations	18	16 (2)	16 (2)
• DuoTrav^®	12	10 (2)	10 (2)
• Xalacom^®	6	6 (0)	6 (0)
More than one prior IOP-lowering therapy	21	21 (0)	21 (0)
Unavailable prior IOP-lowering therapy	100	95 (5)	87 (13)

Notes: The bold IOP-lowering therapies represent the subset of 268 subjects who switched from prior IOP-lowering monotherapy to bimatoprost 0.01% monotherapy and were the focus of analysis in this report. Manufacturer details are as follows: Alphagan^®, Alphagan^® P, Betagan^®, Combigan^®, Lumigan^® (Allergan, Inc., Irvine, CA, USA): Azarga^®, Betoptic^®, Azopt^®, DuoTrav^®, Travatan^®, Travatan Z^® (Alcon Laboratories, Inc., Fort Worth, TX, USA); Timoptic^®, Timoptic XE^®, Trusopt^®, Cosopt^® (Merck & Co., Inc., Whitehouse Station, NJ, USA); Xalacom^®, Xalatan^® (Pfizer, Inc., New York, NY, USA).

Table 2 Early discontinuation due to treatment-related ocular adverse events

Adverse event	Subjects, n (%)	Events, n
Eye pruritus	1 (0.4)	2
Ocular hyperemia	1 (0.4)	2
Drug ineffective	1 (0.4)	1
Foreign body sensation in eyes	1 (0.4)	1
Erythema	1 (0.4)	1
Sensation of foreign body	1 (0.4)	1
Conjunctivitis	1 (0.4)	1

Table 3 Overall rates of occurrence and severity of ocular hyperemia

Hyperemia grade	Number (%) of subjects with each hyperemia grade
	Baseline	Week 6	Week 12
n (missing)	268 (0)	253 (15)	237 (31)
0	93 (34.7%)	91 (36.0%)	89 (37.6%)
+0.5	80 (29.9%)	91 (36.0%)	94 (39.7%)
+1	66 (24.6%)	51 (20.2%)	40 (16.9%)
+2	25 (9.3%)	19 (7.5%)	13 (5.5%)
+3	4 (1.5%)	1 (0.4%)	1 (0.4%)

Table 4 Rates of ocular hyperemia by prior intraocular pressure-lowering therapy

Prior intraocular pressure-lowering therapy	Number (%) of subjects with none-to-mild hyperemia/moderate-to-severe hyperemia
	Baseline		Week 6		Week 12
	None-to-mild	Moderate-to-severe	None-to-mild	Moderate-to-severe	None-to-mild	Moderate-to-severe
Latanoprost 0.005%	108 (95.6)	5 (4.4)	100 (94.3)	6 (5.7)	93 (94.9)	5 (5.1)
Bimatoprost 0.03%	45 (71.4)	18 (28.6)	52 (89.7)	6 (10.3)	49 (92.5)	4 (7.5)
Travoprost 0.004%	13 (81.3)	3 (18.8)	14 (87.5)	2 (12.5)	15 (93.8)	1 (6.3)
Travoprost 0.004% with SofZia™	33 (91.7)	3 (8.3)	33 (91.7)	3 (8.3)	32 (91.4)	3 (8.6)
Nonselective beta-adrenergic receptor blockers	40 (100.0)	0 (0.0)	34 (91.9)	3 (8.1)	34 (97.1)	1 (2.9)

Notes: None-to-mild hyperemia = grades 0, +0.5, or +1; moderate-to-severe hyperemia = grades +2 or +3. Bimatoprost (Lumigan^®, Allergan, Inc., Irvine, CA, USA); Latanoprost (Xalatan^®, Pfizer, Inc., New York, NY, USA); Travoprost (Travatan^®, Alcon Laboratories, Inc., Fort Worth, TX, USA); Travoprost with SofZia™ (Travatan Z^®, Alcon Laboratories, Inc.).

Table 5 Change in ocular hyperemia following switch from prior intraocular pressure-lowering therapy

	Week 6, improved	Week 6, no change	Week 6, worsened	P-value	Week 12, improved	Week 12, no change	Week 12, worsened	P-value
Latanoprost	0.0%	96.2%	3.8%	0.046	1.0%	94.9%	4.1%	0.180
Bimatoprost 0.03%	19.0%	77.6%	3.4%	0.013	20.8%	77.4%	1.9%	0.004
Travoprost 0.004%	12.5%	81.3%	6.3%	0.564	12.5%	87.5%	0.0%	0.157
Travoprost 0.004% with SofZia™	8.3%	83.3%	8.3%	1.000	8.6%	82.9%	8.6%	1.000
Nonselective beta-adrenergicreceptor blockers	0.0%	91.9%	8.1%	0.083	0.0%	97.1%	2.9%	0.317

Notes: Bimatoprost (Lumigan^®, Allergan, Inc., Irvine, CA, USA); Latanoprost (Xalatan^®, Pfizer, Inc., New York, NY, USA); Travoprost (Travatan^®, Alcon Laboratories, Inc., Fort Worth, TX, USA); Travoprost with SofZia™ (Travatan Z^®, Alcon Laboratories, Inc.).

Table 6 Intraocular pressure (IOP) values by prior IOP-lowering therapy

Prior IOP-lowering Therapy	Baseline	Week 6			Week 12
	Mean IOP, mmHg ± SD	Mean IOP, mmHg ± SD	Mean % change in IOP ± SD	P-value*	Mean IOP, mmHg ± SD	Mean % change in IOP ± SD	P-value*
Latanoprost 0.005%	19.8±3.7 (n=113)	16.8±4.1 (n=106)	−15.1±14.5 (n=106)	<0.001	16.7±4.3 (n=98)	−15.2±15.6 (n=98)	<0.001
Bimatoprost 0.03%	17.9±3.6 (n=63)	17.0±3.7 (n=58)	−3.4±16.0 (n=58)	0.114	17.4±4.3 (n=53)	−2.3±17.3 (n=53)	0.342
Travoprost 0.004%	20.8±4.5 (n=16)	18.4±3.5 (n=16)	−8.9±19.9 (n=16)	0.094	18.0±3.7 (n=16)	−12.5±14.4 (n=16)	0.004
Travoprost 0.004% with SofZia™	19.9±4.0 (n=36)	18.0±4.2 (n=36)	−9.4±12.2 (n=36)	<0.001	17.8±3.3 (n=35)	−9.5±14.0 (n=35)	<0.001
Nonselective beta-adrenergic receptor blockers	21.6±4.1 (n=40)	17.1±3.9 (n=37)	−20.6±14.8 (n=37)	<0.001	15.9±3.6 (n=35)	−26.3±12.4 (n=35)	<0.001

Notes:

* P-values calculated for % change from baseline IOP. Bimatoprost (Lumigan^®, Allergan, Inc., Irvine, CA, USA); Latanoprost (Xalatan^®, Pfizer, Inc., New York, NY, USA); Travoprost (Travatan^®, Alcon Laboratories, Inc., Fort Worth, TX, USA); Travoprost with SofZia™ (Travatan Z^®, Alcon Laboratories, Inc.).

Abbreviation: SD, standard deviation.