Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study

Abstract

Purpose To evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients. Methods This was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0-3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score. Results Forty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n = 1; prednisolone acetate 1%, n = 0) and increased intraocular pressure or ocular hypertension (n = 2/group). Mean intraocular pressure values during treatment were 2-3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n = 30 (78.9%); prednisolone acetate 1%, n = 31 (77.5%)). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n = 12 (30.8%) vs n = 7 (17.5%)) and day 8 (n = 18 (48.7%) vs n = 10 (25.0%)). Conclusions Difluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0-3 years undergoing cataract surgery.

Neovascular age‐related macular degeneration is associated with cataract surgery

“…; Wilson et al. ). Inflammation induced by cataract surgery may exacerbate the rate of AMD progression (Donoso et al.…”

To Study the Efficacy of Difluprednate Ophthalmic Emulsion and Prednisolone Acetate Ophthalmic Suspension on Post- operative Inflammation in Cataract Surgery

“…Wilson ME in his study in paediatric patients (age group 0-3year) found difluprednate to be equally safe and efficient in controlling post cataract surgery inflammation as prednisolone acetate eye drops [16].…”

The role of Dexamethasone in clinical pharmaceutical treatment for patients with cataract surgery

“…The efficacy of DEX, IND and CIP was also evaluated determined by AC inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing in patients after cataract surgery. Currently, comparative studies of anti-inflammatory drugs for control of post cataract surgery AC inflammation have been proposed in clinic (21)(22)(23). Previous study has evaluated the efficacy of intracameral dexamethasone predisposes to glaucoma after pediatric cataract surgery (24).…”