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M.S. Seward, D.L. Cooke, L.R. Grillone, R.M. Sacks, Bromfenac Study Group; Topical XibromTm 0.09%, Significantly Reduced Ocular Pain Following Cataract Surgery . Invest. Ophthalmol. Vis. Sci. 2006;47(13):679.
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To evaluate ocular pain reduction following treatment with XibromTM (bromfenac ophthalmic solution) 0.09%, compared with vehicle – placebo dosed b.i.d. for 14 days following cataract surgery in two Phase III randomized studies conducted under a common protocol.
Subjects with a cell + flare score ≥3 post cataract surgery, with no prior anti–inflammatory medication, were randomly assigned to Xibrom or placebo (2:1). Treatment was initiated 16–32 hrs post surgery. Subjects rated each of 7 ocular symptoms (including ocular pain) as none, mild, moderate, or severe within 1 hour after each self–instillation of test agent. Time to resolution of eye pain (days from baseline to time when pain was first scored ‘none’ in diary), was analyzed by Kaplan–Meier estimation of the median. Subjects were censored if event occurred prior to resolution of pain: withdrawal from study, receipt of alternative anti–inflammatory medication, or study end, whichever came first. Subjects who recorded no pain at first diary entry were ’pain free’ as of day 1 and all subsequent time points. Lost to follow–up counted as ‘pain’ at all time points. Those with at least 1 pain free response on or before a time point were counted as ‘pain free’ from that point.
527 subjects were randomized to Xibrom (356) or placebo (171). 118 reported eye pain (Xibrom, 71; placebo, 47). Median time to resolution of ocular pain was 2 days (Xibrom) vs. 5 days (placebo), p < 0.0001, log rank test. In the absence of any anti–inflammatory pretreatment, the effect of Xibrom (b.i.d.) on pain was seen after 1–2 doses post surgery (Day 1); 86.8% in the Xibrom group were pain free for at least 1 diary entry vs 73.7% (placebo). By Day 3 (4–6 doses), 98.3% (Xibrom) had at least 1 pain free response vs 83.6% (placebo), and by Day 15 (28 doses), 99.4% (Xibrom) reported at least 1 pain free response vs 89.5% (placebo).
Xibrom 0.09%, a b.i.d. NSAID was effective for the rapid resolution of ocular pain post cataract surgery with a statistically significant difference between the Xibrom and placebo groups. No pretreatment with Xibrom was required to achieve success.
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