title: Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study.
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.
authors.affiliation: Storm Eye Institute, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: M E
authors.initials: ME
authors.lastname: Wilson
authors.affiliation: Rady Children's Hospital, San Diego, CA, USA.
authors.forename: H
authors.initials: H
authors.lastname: O'Halloran
authors.affiliation: Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: D
authors.initials: D
authors.lastname: VanderVeen
authors.affiliation: Department of Ophthalmology, Children's Hospital of Michigan, Wayne State University School of Medicine, Detroit, MI, USA.
authors.forename: J
authors.initials: J
authors.lastname: Roarty
authors.affiliation: Indiana University Medical Center, Indianapolis, IN, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Plager
authors.affiliation: Alcon Research Ltd, Fort Worth, TX, USA.
authors.forename: K
authors.initials: K
authors.lastname: Markwardt
authors.affiliation: Alcon Research Ltd, Fort Worth, TX, USA.
authors.forename: K
authors.initials: K
authors.lastname: Gedif
authors.affiliation: Department of Ophthalmology, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Lambert
mesh_terms: D000287:Administration, Topical; D001036:Aphakia, Postcataract / Q000209:etiology / Q000601:surgery; D002386:Cataract / Q000151:congenital; D002387:Cataract Extraction / Q000009:adverse effects*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005477:Fluprednisolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007249:Inflammation / Q000188:drug therapy* / Q000209:etiology; D007429:Intraocular Pressure / Q000187:drug effects; D019654:Lens Implantation, Intraocular; D008297:Male; D009883:Ophthalmic Solutions; D011239:Prednisolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology
chemical_list: D005938:Glucocorticoids; D009883:Ophthalmic Solutions; C009935:prednisolone acetate; D005477:Fluprednisolone; D011239:Prednisolone; C015808:difluprednate