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T. L. Comstock, M. R. Paterno, A. Singh, T. A. Erb, E. A. Davis; Safety and Efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% in a Human Postoperative Inflammation Model. Invest. Ophthalmol. Vis. Sci. 2010;51(13):1979.
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© ARVO (1962-2015); The Authors (2016-present)
To compare the safety and efficacy of loteprednol etabonate (LE) ophthalmic ointment, 0.5% to vehicle for the treatment of inflammation and pain following cataract surgery.
Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies. Subjects aged ≥18 years, with a combined postoperative (Day 1) anterior chamber cells and flare of ≥ grade 3 following uncomplicated cataract surgery, participated in 7 study visits. Subjects self-administered study treatment to the lower cul-de-sac of the study eye, four times daily at 4 hour intervals for 14 days. The primary efficacy outcomes were  the proportion of subjects with complete resolution of anterior chamber inflammation and  the proportion of subjects with grade 0 (no) pain on Day 8. Safety outcomes included the incidence of AEs, change in IOP, and an assessment of ocular signs and symptoms.
400 subjects were randomized in study 1 (201 LE ointment; 199 vehicle) and 405 in study 2 (203 LE ointment; 202 vehicle). LE was significantly better compared to vehicle for both primary outcomes: LE ointment rates were higher than vehicle for resolution of inflammation (23.9% vs. 13.6%, P=0.0082 for study 1; 31.5% vs. 11.4%, P<0.0001 for study 2) and for Grade 0 (no) pain (77.6% vs. 45.2 %, for study 1; 73.4% vs. 41.1%, for study 2, P<0.0001 for both) at Day 8. Fewer patients in the LE ointment group compared to vehicle group required rescue medication (68 vs. 128 in study 1; 62 vs. 132 in study 2), and fewer patients in the LE ointment group had ocular AEs compared to vehicle group (54.7% vs. 80.9% in study 1; 39.7% vs. 75.1%, P<0.0001 for both) prior to rescue meds. Individual ocular AEs occurring less frequently in the LE ointment group included anterior chamber inflammation, eye pain, conjunctival hyperemia, and eye pruritus. There were 4 reports of increased IOP (≥10 mm Hg) prior to rescue meds (1 vehicle and 3 LE ointment). Additional safety findings (VA, fundus examination) were unremarkable.
LE ophthalmic ointment, 0.5% was superior to vehicle and efficacious in the resolution of anterior chamber inflammation and pain following cataract surgery. LE Ophthalmic ointment, 0.5% was safe and well tolerated.
Clinical Trial: :
www.clinicaltrials.gov NCT00645671, NTC00699153
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