Advances in Corticosteroid Therapy for Ocular Inflammation: Loteprednol Etabonate

Table 2

Loteprednol etabonate: summary of randomized, controlled, clinical safety and efficacy studies in postoperative inflammation.

Treatment duration and study treatments	Efficacy	Safety	Reference
2 weeks LE 0.5% (𝑛=109) versus placebo (𝑛=113)	(i) Resolution of ACI at final visit: 64% versus 29% (𝑃<0.001 versus placebo); (ii) Treatment failure rate: 6% versus 30% (𝑃<0.001 versus placebo); (iii) Investigator global assessment of treatment effect (𝑃<0.001 versus placebo); (iv) Grade 0 (no pain) at final visit: 85% versus 54% (𝑃=0.003)	↑ IOP (≥10 mm Hg); 𝑛=3 for LE; 𝑛=0 for placebo; Mean IOP decreased in both groups; ≥1 AE: 58% versus 80%; (𝑃<0.001)	[41, 42]
2 weeks LE 0.5% (𝑛=102) versus placebo (𝑛=101)	(i) Resolution of ACI at final visit: 55% versus 28% (𝑃<0.001); (ii) Treatment failure rate: 7% versus 32% (𝑃<0.001 versus placebo); (iii) Investigator global assessment of treatment effect (𝑃<0.001 versus placebo); (iv) Grade 0 (no pain) at final visit: 83% versus 59% (𝑃=0.018)	↑ IOP ≥10 mm Hg); 𝑛=0 for LE; 𝑛=1 for placebo; Mean IOP decreased in both groups; ≥1 AE: 54% versus 75%; (𝑃=0.002)	[6, 42]
2 weeks LE 0.5% ointment (𝑛=404) versus vehicle (𝑛=401) [2 studies]	(i) Resolution of ACI at day 8: 27.7% versus 12.5% (𝑃<0.0001); (ii) Grade 0 (no pain) at day 8: 75.5% versus 43.1% (𝑃<0.0001); (iii) Need for rescue medication: 27.7% versus 63.8% (𝑃<0.0001)	↑ IOP (≥10 mm Hg): 𝑛=3 for LE; 𝑛=1 for vehicle; Mean IOP decreased in both groups; Mean IOP decreased in both groups; ≥1 AE: 47.2% versus 78.0% (𝑃<0.0001)	[45]

LE: loteprednol etabonate, IOP: intraocular pressure, ACI: anterior chamber inflammation, AE: adverse event.