Eric D Donnenfeld1, Edward J Holland, Kerry D Solomon. 1. From the Department of Ophthalmology, New York University (Donnenfeld), New York, New York, Cincinnati Eye Institute (Holland), Edgewood, Kentucky, Carolina Eyecare Physicians, LLC (Solomon), Mount Pleasant, South Carolina, USA.
Abstract
PURPOSE: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery. SETTING: Three U.S. clinical sites. DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study. METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively. RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group. CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.
PURPOSE: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery. SETTING: Three U.S. clinical sites. DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study. METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively. RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group. CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.