Abstract
Purpose :
Difluprednate ophthalmic emulsion 0.05% is a topical ocular corticosteroid for treatment of inflammation and pain associated with ocular surgery. Surgical removal of cataract remains the only treatment for patient with senile cataract. The current study was designed to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin® SF) for postoperative inflammation and pain in patients with senile cataract
Methods :
This was a phase III, multicenter, prospective, double-blind, clinical trial. It was conducted in seven centers in Mexico. A total of 171 subjects were randomized (1:1) and completed the study. Subjects were assigned to receive either difluprednate (n=85), or prednisolone (n=86), see Figure 1. Patients instilled a drop four times a day (QID) for 14 days (then tapering dose downward for 14 days). The primary efficacy endpoint was anterior chamber (AC) cell grade. Other results measured included, retinal central thickness (by OCT), conjunctival hyperemia, edema, pain and photophobia. Safety was assay by visual acuity (VA), intraocular pressure (IOP) and incidence of Adverse Events (AE). Tolerability was evaluating by burning, itching and foreign body sensation. The study was registered at ClinicalTrials.gov as NCT03693989.
Results :
Compared with the baseline, there was a significant improvement in the CA cell grade in both groups (p=0.0001). There was a significant increase in retinal central thickness compared with their baseline (PRO-145: 253.59 ± 26.9µm vs 243.34 ± 27.4µm and prednisolone: 263.38 ± 34.4µm vs 248.38 ± 25.6µm, p=0.0001). Similar improvements were observed in the conjunctival hyperemia at week 4 (81.2% vs 79%, p=0.0001 vs baseline), edema (82.4% vs 82.5%, p=0.0001 vs baseline), pain (15.3% vs 7%, p=0.0001 vs baseline) and photophobia (16.4% vs 15.1%, p=0.0001 vs baseline), see Table 1. There were no significant differences between treatments for adverse events and VA. A significant difference was observed in IOP for PRO-145 (p=0.045), at the final visit. Finally, there were no significant difference between treatments for any tolerability parameter
Conclusions :
Difluprednate 0.05% is as effective and safe as prednisolone acetate 1% for postoperative inflammation and pain undergoing phacoemulsification in patients with senile cataract
This is a 2020 ARVO Annual Meeting abstract.