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

M. E. Wilson, H. O'Halloran, D. VanderVeen, J. Roarty, David Plager, K. Markwardt, K. Gedif, S. R. Lambert

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1187-1194
Number of pages8
JournalEye (London, England)
Volume30
Issue number9
DOIs
StatePublished - Sep 1 2016

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Cataract
Pediatrics
Inflammation
Safety
Intraocular Pressure
Corneal Edema
Ocular Hypertension
Withholding Treatment
Intraocular Lens Implantation
Anterior Chamber
Emulsions
Drug-Related Side Effects and Adverse Reactions
Ambulatory Surgical Procedures
difluprednate
prednisolone acetate
Therapeutics
Incidence

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients : a randomized safety and efficacy study. / Wilson, M. E.; O'Halloran, H.; VanderVeen, D.; Roarty, J.; Plager, David; Markwardt, K.; Gedif, K.; Lambert, S. R.

In: Eye (London, England), Vol. 30, No. 9, 01.09.2016, p. 1187-1194.

Research output: Contribution to journalArticle

Wilson, M. E. ; O'Halloran, H. ; VanderVeen, D. ; Roarty, J. ; Plager, David ; Markwardt, K. ; Gedif, K. ; Lambert, S. R. / Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients : a randomized safety and efficacy study. In: Eye (London, England). 2016 ; Vol. 30, No. 9. pp. 1187-1194.
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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.",
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AU - Wilson, M. E.

AU - O'Halloran, H.

AU - VanderVeen, D.

AU - Roarty, J.

AU - Plager, David

AU - Markwardt, K.

AU - Gedif, K.

AU - Lambert, S. R.

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N2 - 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.

AB - 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.

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