<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

Abstract

Background: The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin ® SF), for management of postoperative inflammation and pain, after cataract surgery. Methods: This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intentto-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). Results: A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). Conclusion: The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.

Therapeutic Efficacy of Difluprednate 0.05% Versus Prednisolone Acetate 1% in Controlling Inflammation and Macular Oedema Following Phacoemulsification: An Optical Coherence Tomography-Based Study

“…No significant differences in the analysis of AC cells and flare were observed between the two drug groups at any time of follow-up in a multicenter RCT studied in Mexico [ 21 ]. Khalaf Allah et al, in their systematic review, have reported that after small incision cataract surgery, difluprednate was superior in clearing AC cells at one week (OR=2.5, p>0.00001) and at two weeks (OR=2.5, p=0.04), as well as clearing the AC flare at two weeks (OR=6.7, p=0.04).…”

“…However, if this persists for a long time, it causes intraretinal cystic spaces, otherwise called subclinical cystoid macular oedema (SCME) [ 19 , 20 ]. The postsurgical inflammation in the macula following topical steroid administration has not been studied adequately using OCT [ 19 - 21 ]. Few studies on spectral-domain OCT documented the resolution of pseudophakic CME after administration of topical difluprednate [ 19 - 21 ].…”

“…The postsurgical inflammation in the macula following topical steroid administration has not been studied adequately using OCT [ 19 - 21 ]. Few studies on spectral-domain OCT documented the resolution of pseudophakic CME after administration of topical difluprednate [ 19 - 21 ]. To the best of our knowledge, there is only one comparative study between difluprednate 0.05% and prednisolone acetate in the postphacoemulsification period using OCT [ 21 ].…”

“…Few studies on spectral-domain OCT documented the resolution of pseudophakic CME after administration of topical difluprednate [ 19 - 21 ]. To the best of our knowledge, there is only one comparative study between difluprednate 0.05% and prednisolone acetate in the postphacoemulsification period using OCT [ 21 ]. Palacio-Pastrana et al did not find any difference in central retinal thickness, conjunctival hyperemia, oedema, pain and photophobia between the two drugs [ 21 ].…”

“…To the best of our knowledge, there is only one comparative study between difluprednate 0.05% and prednisolone acetate in the postphacoemulsification period using OCT [ 21 ]. Palacio-Pastrana et al did not find any difference in central retinal thickness, conjunctival hyperemia, oedema, pain and photophobia between the two drugs [ 21 ]. Accordingly, the present study was designed to compare the efficacy and safety of difluprednate 0.05% emulsion versus 1% prednisolone acetate in controlling SCME using swept-source OCT.…”