Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery

Figures & data

Figure 1 Flow of patients through the study.

Abbreviations: AE, adverse event; LE, loteprednol etabonate.

Table 1 Demographics, intent-to-treat population

	LE ointment (n = 404)	Vehicle (n = 401)	Overall (n = 805)
Age (years)
Mean (SD)	68.7 (9.26)	69.2 (9.06)	69.0 (9.16)
Minimum, maximum	21, 92	38, 94	21, 94
<65	116 (28.7%)	105 (26.2%)	221 (27.5%)
≥65	177 (43.8%)	185 (46.1%)	362 (45.0%)
≥75	111 (27.5%)	111 (27.7%)	222 (27.6%)
Gender
Male	171 (42.3%)	167 (41.6%)	338 (42.0%)
Female	233 (57.7%)	234 (58.4%)	467 (58.0%)
Race
White	365 (90.3%)	357 (89.0%)	722 (89.7%)
Nonwhite	39 (9.7%)	44 (11.0%)	83 (10.3%)

Abbreviations: LE, loteprednol etabonate; SD, standard deviation.

Figure 2 Proportion of patients with rescue medication use prior to each visit.

Abbreviation: LE, loteprednol etabonate.

Table 2 Resolution of anterior chamber cells and flare and pain at visit 5: integrated intent-to-treat population

	LE ointment (n = 404)	Vehicle (n = 401)	Difference (95% CI)bP valuec
Complete resolution of anterior chamber cells and flarea	112 (27.7%)	50 (12.5%)	15.3% (9.6%, 20.9%) <0.0001
Grade 0 (no) paina	305 (75.5%)	173 (43.1%)	32.4% (25.7%, 39.0%) <0.0001

Notes:

a Patients who had missing data or took rescue medication prior to visit 5 were imputed as failures;

b Difference in percentages; 95% CI based on asymptotic normal approximations;

c P values from Pearson χ² test.

Abbreviations: LE, loteprednol etabonate; CI, confidence interval.

Figure 3 Proportion of patients with complete resolution of anterior chamber inflammation A), complete resolution of anterior chamber cells B), complete resolution of anterior chamber flare C), and no (Grade 0) pain D) at each study visit.

Notes: Visit 4 = day 3 (±1 day); visit 5 = day 8 (±1 day); visit 6 = day 15 (±1 day); visit 7 = day 18 (±1 day). *P < 0.0001; ^†P = 0.0008.
Abbreviation: LE, loteprednol etabonate.

Table 3 Ocular adverse events occurring in ≥3% study eyes in any treatment group prior to rescue medication

	LE ointment (n = 405)	Vehicle (n = 400)	P valuea
Total number of AEs	313	581
Number of patients with at least one AE	191 (47.2%)	312 (78.0%)	<0.0001
Anterior chamber inflammation	110 (27.2%)	200 (50.0%)	<0.0001
Photophobia	22 (5.4%)	31 (7.8%)	0.2025
Corneal edema	18 (4.4%)	23 (5.8%)	0.4264
Conjunctival hyperemia	16 (4.0%)	30 (7.5%)	0.0336
Eye pain	15 (3.7%)	43 (10.8%)	0.0001
Iritis	15 (3.7%)	31 (7.8%)	0.0149
Ciliary hyperemia	10 (2.5%)	23 (5.8%)	0.0208
Anterior chamber cell	10 (2.5%)	16 (4.0%)	0.2375
Lacrimation increased	8 (2.0%)	19 (4.8%)	0.0318
Eye pruritus	6 (1.5%)	19 (4.8%)	0.0080
Anterior chamber flare	6 (1.5%)	14 (3.5%)	0.0731

Notes: Data are the number (%) of eyes.

a P values were calculated using the Fisher’s Exact test. A patient was counted at most once for a given preferred term (except for total number of AEs).

Abbreviations: AEs, adverse events; LE, loteprednol etabonate.

Figure 4 Mean (± standard error of the mean) change from baseline in intraocular pressure (mmHg) by visit.

Abbreviation: LE, loteprednol etabonate.