A comparative study of difluprednate 0.05% nanoemulsion vs prednisolone acetate 1% + phenylephrine 0.12% suspension on postoperative inflammation treatment following cataract surgery

Purpose To investigate if Difluprednate 0.05% nanoemulsion (DIFL) administered once a day (BID) is non‐inferior than Prednisolone acetate 1% + Phenylephrine hydrochloride 0.12% (P+P) administered four times a day (QID), on post‐operative inflammation treatment following cataract surgery. Methods A multicentric, randomized, double‐masked, parallel‐group, non‐inferiority study was performed in 259 patients who underwent phacoemulsification. Primary endpoint was corneal thickness. Non‐inferior anti‐inflammatory efficacy was considered if the difference in corneal thickness between baseline and Day 4 did not differ beyond 17 µm between treatments. Secondary endpoints were cell & flare, best‐corrected visual acuity (BCVA), endothelial cell count, OCT‐central macular thickness, and intraocular pressure (IOP). All outcomes were evaluated at baseline, day 1, 4, and 28 after surgery. Results 225 patients finished the study. The difference in corneal thickness at baseline and Day 4 did not differ beyond 17 µm between treatments (IC95% −2.78 µm – 14.84 µm), with no statistically significant differences between treatments (p = 0.523). There were no statistically significant differences between groups in flare & cells at all study times (p > 0.05). No statistically significant differences were reported between treatments in BCVA (p = 0.455), although BCVA logMAR improved in DIFL group at Day 1 (from 0.198 to 0.177), while P+P group did not improve (from 0.219 to 0.234). No statistically significant differences were reported in endothelial cell count (p = 0.811), OCT‐central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316). At Day 28, four patients reported elevated IOP (>21 mmHg), three of which belonged to P+P. Conclusions Difluprednate 0.05% ophthalmic nanoemulsion administered BID is at least as effective as Prednisolone acetate 1% + Phenylephrine 0.12% suspension administered QID on anti‐inflammatory treatment following cataract surgery.