Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation after cataract surgery in children

PURPOSE: To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate (PA) suspension 1% for the treatment of inflammation after cataract surgery in children. SETTING: Eleven sites in the United States. DESIGN: Randomized, double-masked, parallel-group, noninferiority study. METHODS: Eligible patients were ≤11 years of age and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week post-surgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, AC inflammation (ACI), synechiae, precipitates on the implant/cornea, visual acuity, and intraocular pressure (IOP). RESULTS: The intent-to-treat population comprised 105 patients (LE gel, n=53; PA 1%, n=52) including 52 patients aged ≤3 years. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI = -0.281 to 0.292). Similar ACI outcomes were observed in patients ≤3 years of age. LE gel and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, 28 post-surgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P≥0.06). Synechiae and corneal/implant precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases. CONCLUSIONS: LE gel 0.5% was safe and effective in treating pediatric post-cataract surgical inflammation, with similar outcomes as PA 1%.