Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery
Stephen Smith1, Douglas Lorenz2, James Peace3, Kimberly McLeod4, RS Crockett5, Roger Vogel4, and the Difluprednate ST601-004 Study Group1Eye Associates of Fort Myers, Fort Myers, Florida, USA; 2Nevada Eye and Ear, Henderson, Nevada, USA; 3United Medical Research, Inglewood, California, USA; 4Sirion...
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Dove Medical Press
2010
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oai:doaj.org-article:4a240891a527411892e0e3b610fffc8f2021-12-02T01:42:37ZDifluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery1177-54671177-5483https://doaj.org/article/4a240891a527411892e0e3b610fffc8f2010-08-01T00:00:00Zhttp://www.dovepress.com/difluprednate-ophthalmic-emulsion-005-durezolreg-administered-two-time-a5157https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Stephen Smith1, Douglas Lorenz2, James Peace3, Kimberly McLeod4, RS Crockett5, Roger Vogel4, and the Difluprednate ST601-004 Study Group1Eye Associates of Fort Myers, Fort Myers, Florida, USA; 2Nevada Eye and Ear, Henderson, Nevada, USA; 3United Medical Research, Inglewood, California, USA; 4Sirion Therapeutics, Inc., Tampa, Florida, USA; 5DATA, Inc., Bayou La Batre, Alabama, USA. Clinical trial registration number: NCT00616993Objective: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic ­emulsion 0.05% (Durezol®) versus placebo administered before surgery for managing inflammation and pain following cataract extraction.Methods: Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day ­tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of ­inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed.Results: Clearing of inflammation on day 14 (primary endpoint), defined as an AC cell grade of 0 (≤5 cells) and a flare grade of 0 (complete absence), was achieved in a significantly greater percentage of subjects treated with difluprednate, compared with placebo (74.7% ­vs 42.5%; P = 0.0006). A significantly greater percentage of difluprednate-treated subjects were free of ocular pain/discomfort on day 14 than placebo-treated subjects (64.6% vs 30.0%; P = 0.0004). Three subjects (3.7%) in the difluprednate group had a clinically significant IOP rise (defined as ≥21 mmHg and a change from baseline ≥10 mmHg at same visit).Conclusions: Difluprednate, administered 2 times daily starting 24 hours before cataract ­surgery, was highly effective for managing ocular inflammation and relieving pain and discomfort postoperatively. Difluprednate was well tolerated and provides a convenient twice-daily option for managing postoperative ocular inflammation.Keywords: difluprednate, safety, efficacy, twice daily, postoperative ocular inflammation, corticosteroids Stephen SmithDouglas LorenzJames Peaceet al.Dove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2010, Iss default, Pp 983-991 (2010) |
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Ophthalmology RE1-994 |
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Ophthalmology RE1-994 Stephen Smith Douglas Lorenz James Peace et al. Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| description |
Stephen Smith1, Douglas Lorenz2, James Peace3, Kimberly McLeod4, RS Crockett5, Roger Vogel4, and the Difluprednate ST601-004 Study Group1Eye Associates of Fort Myers, Fort Myers, Florida, USA; 2Nevada Eye and Ear, Henderson, Nevada, USA; 3United Medical Research, Inglewood, California, USA; 4Sirion Therapeutics, Inc., Tampa, Florida, USA; 5DATA, Inc., Bayou La Batre, Alabama, USA. Clinical trial registration number: NCT00616993Objective: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic ­emulsion 0.05% (Durezol®) versus placebo administered before surgery for managing inflammation and pain following cataract extraction.Methods: Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day ­tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of ­inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed.Results: Clearing of inflammation on day 14 (primary endpoint), defined as an AC cell grade of 0 (≤5 cells) and a flare grade of 0 (complete absence), was achieved in a significantly greater percentage of subjects treated with difluprednate, compared with placebo (74.7% ­vs 42.5%; P = 0.0006). A significantly greater percentage of difluprednate-treated subjects were free of ocular pain/discomfort on day 14 than placebo-treated subjects (64.6% vs 30.0%; P = 0.0004). Three subjects (3.7%) in the difluprednate group had a clinically significant IOP rise (defined as ≥21 mmHg and a change from baseline ≥10 mmHg at same visit).Conclusions: Difluprednate, administered 2 times daily starting 24 hours before cataract ­surgery, was highly effective for managing ocular inflammation and relieving pain and discomfort postoperatively. Difluprednate was well tolerated and provides a convenient twice-daily option for managing postoperative ocular inflammation.Keywords: difluprednate, safety, efficacy, twice daily, postoperative ocular inflammation, corticosteroids |
| format |
article |
| author |
Stephen Smith Douglas Lorenz James Peace et al. |
| author_facet |
Stephen Smith Douglas Lorenz James Peace et al. |
| author_sort |
Stephen Smith |
| title |
Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| title_short |
Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| title_full |
Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| title_fullStr |
Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| title_full_unstemmed |
Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| title_sort |
difluprednate ophthalmic emulsion 0.05% (durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery |
| publisher |
Dove Medical Press |
| publishDate |
2010 |
| url |
https://doaj.org/article/4a240891a527411892e0e3b610fffc8f |
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