Difluprednate 0.05% twice a day vs prednisolone acetate 1% 4 times a day for cataract postsurgical inflammation treatment: noninferiority trial

Purpose To establish if Difluprednate 0.05% nanoemulsion (DIFL) twice a day (BID) is as effective as Prednisolone acetate 1% + Phenylephrine hydrochloride 0.12% suspension (PRED) four times a day (QID) on postsurgical inflammation treatment. Setting 4 private Argentine ophthalmological centers. Design Non-inferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial. Methods A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Non-inferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and Day 4 did not differ beyond 17 µm between treatments. Secondary endpoints were cell & flare, corrected distance visual acuity (CDVA), 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% -2.78µm - 14,84 µm), with no statistically significant difference between treatments (p = 0.523). There were not statistically significant differences between groups on total anterior chamber clearance at any study time (p > 0.05). No statistically significant differences were reported between treatments in CDVA (p = 0.455), endothelial cell count (p = 0.811), OCT-central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316). Conclusions Difluprednate administered BID is at least as effective as Prednisolone acetate administered QID on inflammatory treatment following cataract surgery.