@article {836996,
	title = {Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study.},
	journal = {Eye (Lond)},
	volume = {30},
	number = {9},
	year = {2016},
	month = {2016 Sep},
	pages = {1187-94},
	abstract = {PurposeTo evaluate safety and efficacy of difluprednate 0.05\% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.MethodsThis 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.ResultsForty 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\%).ConclusionsDifluprednate 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.},
	issn = {1476-5454},
	doi = {10.1038/eye.2016.132},
	author = {Wilson, M E and O{\textquoteright}Halloran, H and VanderVeen, D and Roarty, J and Plager, D A and Markwardt, K and Gedif, K and Lambert, S R}
}
