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Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study
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 u...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5023802/ https://www.ncbi.nlm.nih.gov/pubmed/27367745 http://dx.doi.org/10.1038/eye.2016.132 |
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author | Wilson, M E O'Halloran, H VanderVeen, D Roarty, J Plager, D A Markwardt, K Gedif, K Lambert, S R |
author_facet | Wilson, M E O'Halloran, H VanderVeen, D Roarty, J Plager, D A Markwardt, K Gedif, K Lambert, S R |
author_sort | Wilson, M E |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5023802 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-50238022016-09-21 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, D A Markwardt, K Gedif, K Lambert, S R Eye (Lond) Clinical Study 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. Nature Publishing Group 2016-09 2016-07-01 /pmc/articles/PMC5023802/ /pubmed/27367745 http://dx.doi.org/10.1038/eye.2016.132 Text en Copyright © 2016 The Author(s) http://creativecommons.org/licenses/by/4.0/ This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Clinical Study Wilson, M E O'Halloran, H VanderVeen, D Roarty, J Plager, D A 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 |
title | Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
title_full | Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
title_fullStr | Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
title_full_unstemmed | Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
title_short | Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
title_sort | difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5023802/ https://www.ncbi.nlm.nih.gov/pubmed/27367745 http://dx.doi.org/10.1038/eye.2016.132 |
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