PURPOSE:Nepafenac ophthalmic suspension 0.1% was dosed topically once (QD), twice (BID), or three-times (TID) daily to assess the resolution of ocular pain and anterior-segment inflammation following cataract surgery. METHODS: This was a prospective, multicenter, double-masked, randomized, placebo-controlled study of 212 adults. Patients received nepafenac 0.1% or placebo, 1 drop QD, BID, or TID beginning 1 day before cataract surgery, continuing on the day of surgery, and for 14 days thereafter. One (1) additional drop was administered 30-120 min prior to surgery. The primary efficacy endpoint was percent of treatment failures (>or=16 aqueous cells, aqueous flare = severe, or ocular pain score = moderately severe or severe) through postoperative day 14. RESULTS: On days 7 and 14, the QD, BID, and TID all nepafenac posologies significantly reduced the percent of treatment failures, compared to placebo ( p <or= 0.0029). Compared with placebo, the TID posology achieved statistical significance beginning on day 3 ( p <or= 0.0080). Nepafenac treatment significantly increased the proportion of patients with resolved ocular inflammation, compared to placebo, beginning on day 1 for TID dosing ( p <or= 0.0208) and beginning on day 3 for QD dosing ( p <or= 0.0483). A significantly greater percentage of nepafenac-treated patients were pain free, compared to placebo, beginning on postoperative day 1 with BID and TID dosing ( p <or= 0.0150) and beginning on day 3 for QD dosing (p <or= 0.0220). No serious ocular adverse events were reported, and fewer patients experienced adverse events in the nepafenac groups than in the placebo group. CONCLUSIONS:Nepafenac ophthalmic suspension 0.1% was well tolerated and effectively resolved ocular inflammation and increased the incidence of ocular pain-free patients following cataract surgery when dosed QD, BID, or TID. By postoperative day 14, all nepafenac posologies significantly reduced the incidence of treatment failures and the incidence of patients presenting with ocular inflammation, and significantly increased the incidence of ocular pain-free patients relative to placebo.
RCT Entities:
PURPOSE:Nepafenac ophthalmic suspension 0.1% was dosed topically once (QD), twice (BID), or three-times (TID) daily to assess the resolution of ocular pain and anterior-segment inflammation following cataract surgery. METHODS: This was a prospective, multicenter, double-masked, randomized, placebo-controlled study of 212 adults. Patients received nepafenac 0.1% or placebo, 1 drop QD, BID, or TID beginning 1 day before cataract surgery, continuing on the day of surgery, and for 14 days thereafter. One (1) additional drop was administered 30-120 min prior to surgery. The primary efficacy endpoint was percent of treatment failures (>or=16 aqueous cells, aqueous flare = severe, or ocular pain score = moderately severe or severe) through postoperative day 14. RESULTS: On days 7 and 14, the QD, BID, and TID all nepafenac posologies significantly reduced the percent of treatment failures, compared to placebo ( p <or= 0.0029). Compared with placebo, the TID posology achieved statistical significance beginning on day 3 ( p <or= 0.0080). Nepafenac treatment significantly increased the proportion of patients with resolved ocular inflammation, compared to placebo, beginning on day 1 for TID dosing ( p <or= 0.0208) and beginning on day 3 for QD dosing ( p <or= 0.0483). A significantly greater percentage of nepafenac-treated patients were pain free, compared to placebo, beginning on postoperative day 1 with BID and TID dosing ( p <or= 0.0150) and beginning on day 3 for QD dosing (p <or= 0.0220). No serious ocular adverse events were reported, and fewer patients experienced adverse events in the nepafenac groups than in the placebo group. CONCLUSIONS:Nepafenac ophthalmic suspension 0.1% was well tolerated and effectively resolved ocular inflammation and increased the incidence of ocular pain-freepatients following cataract surgery when dosed QD, BID, or TID. By postoperative day 14, all nepafenac posologies significantly reduced the incidence of treatment failures and the incidence of patients presenting with ocular inflammation, and significantly increased the incidence of ocular pain-freepatients relative to placebo.