0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects

Figures & data

Table 1 Anterior Chamber Cell and Flare Grading

Anterior Chamber Cells		Anterior Chamber Flare
Grade	Cell Count	Grade	Flare Count
0	0	0	None: no haze is detected
1	1–10	1	Mild: A faint haze is detected
2	11–20	2	Moderate: Haze is easy to detect, but iris details are not obscured
3	21–50	3	Marked: Haze is prominent, and iris details are somewhat obscured
4	> 50	4	Severe: Haze is dramatic, and iris details are very obscured and/or the aqueous is fibrinoid or plastic

Table 2 Ocular Pain Scale

Grade	Pain Level	Subjective Description
0	None	Absence of pain
1	Trace	Slight, occasional awareness of ocular sensation
2	Mild	Noticeable, intermittent awareness of ocular sensation that has no impact on daily activity
3	Moderate	Prolonged, moderate ocular aching that occasionally interferes with daily activity
4	Severe	Prolonged, intense ocular pain that interferes with normal daily activities

Figure 1 VAS descriptive faces.

Table 3 Summary of Demographic Characteristics, Intent-to-Treat Population

Characteristic	SURF-201 (N=39), n (%)	Vehicle (N=43), n (%)	Overall (N=82), n (%)
Age (years)
Mean (SD)	68.3 (±6.82)	68.4 (±9.90)	68.4 (±8.53)
< 65	11 (28.2%)	14 (32.6%)	25 (30.5%)
≥ 65	28 (71.8%)	29 (67.4%)	57 (69.5%)
Gender
Male	12 (30.8%)	18 (41.9%)	30 (36.6%)
Female	27 (69.2%)	25 (58.1%)	52 (63.4%)
Race
White	31 (79.5%)	33 (76.7%)	64 (78.0%)
Black or African American	7 (17.9%)	9 (20.9%)	16 (19.5%)
Asian	1 (2.6%)	1 (2.3%)	2 (2.4%)

Abbreviation: SD, standard deviation.

Table 4 Anterior Chamber Cell and Flare Outcomes at Each Study Visit, Intent-to-Treat Population

	ACC Grade of 0 (n, %)					ACF Grade of 0 (n, %)
	Day 1	Day 8	Day 15	Day 22*	Day 32*	Day 1	Day 8	Day 15	Day 22*	Day 32*
SURF-201 (N=39)	1 (2.6%)	13 (33.3%)	26 (66.7%)	27 (69.2%)	33^b (86.8%)	13 (33.3%)	23 (59%)	35 (89.7%)	34 (87.2%)	38 (100%)
Vehicle (N=43)	3 (7.0%)	4 (9.8%)^c	16 (40.0%)^c	25 (62.5%)^c	39^c (95.1%)^c	17 (39.5%)	20 (48.8%)	28 (70%)	37 (92.5%)	40 (97.6%)
P-value^a	0.530	0.010	0.019	0.568	0.247	0.596	0.528	0.031	0.531	0.514

Notes: *After primary study endpoint. ^aBarnard’s exact test for differences between proportions. ^bAt Day 32, n=38. ^cAt Days 8, 15, 22, and 32, n=41, n=40, n=40, n=41, respectively.

Table 5 Proportion of Patients with a Visual Analog Scale Pain Score of 0 at Each Study Visit, Intent-to-Treat Population

VAS Score	SURF-201 (N=38)	Vehicle (N=43)	P-value*
	n (%)	n (%)
Baseline	39 (100%)	43 (100%)	--
Day 1	27 (69.2%)	21 (48.8%)	0.066
Day 8	32 (82.1%)	32 (78.0%) (n=41)	0.716
Day 15	35 (89.7%)	33 (82.5%) (n=40)	0.528
Day 22	35 (89.7%)	37 (92.5%) (n=40)	0.766
Day 32	35 (92.1%) (n=38)	39 (95.1%) (n=41)	0.619

Note: *Based on the Barnard’s exact test for differences between proportions.

Table 6 Adverse Events, Safety Population

Adverse Events	SURF-201 (N=40)	Vehicle (N=43)	Overall (N=83)
	n (%)	n (%)	n (%)
Ocular AE	27 (67.5%)	23 (53.5%)	50 (60.2%)
Non-ocular AE	26 (65%)	22 (51.2%)	48 (57.8%)
Ocular TEAE	26 (65%)	23 (53.5%)	49 (59%)
Non-ocular TEAE	25 (62.5%)	22 (51.2%)	47 (56.6%)
Ocular SAE	3 (7.5%)	0 (0%)	3 (3.6%)
System Organ Class/Preferred Term
Subjects with any TEAE*
Eye disorders	25 (62.5%)	22 (51.2%)	47 (56.6%)
VA reduced	6 (15.0%)	10 (23.3%)	16 (19.3%)
Eye inflammation	6 (15.0%)	8 (18.6%)	14 (16.9%)
PCO	5 (12.5%)	6 (14.0%)	11 (13.3%)
Eye pain	5 (12.5%)	4 (9.3%)	9 (10.8%)
Corneal edema	2 (5.0%)	4 (9.3%)	6 (7.2%)
Photophobia	2 (5.0%)	3 (7.0%)	5 (6.0%)
Conjunctival hyperemia	1 (2.5%)	3 (7.0%)	4 (4.8%)
Iritis	3 (7.5%)	1 (2.3%)	4 (4.8%)
Vitreous detachment	3 (7.5%)	1 (2.3%)	4 (4.8%)
Eye irritation	3 (7.5%)	0 (0.0%)	3 (3.6%)
Vitreous floaters	2 (5.0%)	1 (2.3%)	3 (3.6%)
General disorders
IOP increase	4 (10.0%)	1 (2.3%)	5 (6.0%)

Note: *Reporting only those events that occurred in 5.0% or more of patients in either group.

Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event; SAE, serious adverse event; VA, visual acuity; PCO, posterior capsule opacification; IOP, intraocular pressure.

Table 7 Mean Intraocular Pressure at Each Study Visit, Safety Population

Mean IOP	SURF-201 (N=40)	Vehicle (N=43)
Baseline	16.1±2.8 mmHg	15.9±2.84 mmHg
Day 1	17.2±5.49 mmHg	14.7±3.29 mmHg
Day 8	15.4±3.76 mmHg (n=39)	13.6±3.40 mmHg (n=41)
Day 15	14.5±3.06 mmHg (n=39)	13.8±2.72 mmHg (n=41)
Day 22	14.5±2.78 mmHg (n=39)	14.2±2.58 mmHg (n=41)
Day 32	14.1±3.06 mmHg (n=38)	14.2±2.33 mmHg (n=41)