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

Abstract

Purpose: 

To establish whether difluprednate 0.05% nanoemulsion (DIFL) twice a day is as effective as prednisolone acetate 1% + phenylephrine hydrochloride 0.12% suspension (PRED) 4 times a day for postsurgical inflammation treatment.

Setting: 

4 private Argentine ophthalmological centers.

Design: 

Noninferiority, 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. Noninferior 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 and flare, corrected distance visual acuity (CDVA), endothelial cell count, optical coherence tomography (OCT) central macular thickness, and intraocular pressure. All outcomes were evaluated at baseline and day 1, 4, and 28 postoperatively.

Results: 

225 patients finished the study. The difference in corneal thickness at baseline and day 4 did not differ beyond 17 μm between treatments (95% CI −2.78 μm to 14.84 μm), with no statistically significant difference (P = .523). No statistically significant differences were found between groups in total anterior chamber clearance at any study timepoint (P > .05). Moreover, no statistically significant differences were reported between treatments in CDVA (P = .455), endothelial cell count (P = .811), OCT central macular thickness (P = .869), and intraocular pressure outcome (P = .316).

Conclusions: 

Difluprednate administered twice a day was at least as effective as prednisolone acetate administered 4 times a day for inflammatory treatment after cataract surgery.

In Brief

Noninferiority of difluprednate therapy applied twice a day in comparison with standard treatment of prednisolone 1% applied 4 times a day for cataract postsurgical inflammation treatment was supported.