Satish S Modi1, Robert P Lehmann2, Thomas R Walters2, Raymond Fong2, William C Christie2, Lawrence Roel2, David Nethery2, Dana Sager2, Alexis Tsorbatzoglou2, Bo Philipson2, Carlo E Traverso2, Harvey Reiser2. 1. From Alterman, Modi & Wolter (Modi), Poughkeepsie, and the Manhattan Eye, Ear and Throat Hospital (Fong), New York, New York; Lehmann Eye Center (Lehmann), Nacogdoches, Nethery Eye Associates (Nethery), and Alcon Research, Ltd. (Sager), Fort Worth, and Texan Eye, PA (Walters), Austin, Texas; Scott & Christie & Assoc., PC (Christie), Cranberry Township, and Eye Care Specialists (Reiser), Kingston, Pennsylvania; Eastside Westside Research Center (Roel), Spartanburg, South Carolina, USA; Josa Andras Hospital (Tsorbatzoglou), Nyíregyháza, Hungary; Stockholm Eye Clinic (Philipson), Stockholm, Sweden; Clinica Oculistica (Traverso), Di.N.O.G.M.I., University of Genoa, Genoa, Italy. Electronic address: smodieyes@aol.com. 2. From Alterman, Modi & Wolter (Modi), Poughkeepsie, and the Manhattan Eye, Ear and Throat Hospital (Fong), New York, New York; Lehmann Eye Center (Lehmann), Nacogdoches, Nethery Eye Associates (Nethery), and Alcon Research, Ltd. (Sager), Fort Worth, and Texan Eye, PA (Walters), Austin, Texas; Scott & Christie & Assoc., PC (Christie), Cranberry Township, and Eye Care Specialists (Reiser), Kingston, Pennsylvania; Eastside Westside Research Center (Roel), Spartanburg, South Carolina, USA; Josa Andras Hospital (Tsorbatzoglou), Nyíregyháza, Hungary; Stockholm Eye Clinic (Philipson), Stockholm, Sweden; Clinica Oculistica (Traverso), Di.N.O.G.M.I., University of Genoa, Genoa, Italy.
Abstract
PURPOSE: To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammationafter cataract surgery. SETTING: Sixty-five centers in the United States and Europe. DESIGN: Randomized double-masked vehicle- and active-controlled phase 3 study. METHODS: Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14. RESULTS: Of randomized patients, 817 received nepafenac0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P ≤ .0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%. CONCLUSIONS: Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing. FINANCIAL DISCLOSURE: Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery. SETTING: Sixty-five centers in the United States and Europe. DESIGN: Randomized double-masked vehicle- and active-controlled phase 3 study. METHODS:Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14. RESULTS: Of randomized patients, 817 received nepafenac 0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P ≤ .0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%. CONCLUSIONS: Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing. FINANCIAL DISCLOSURE: Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.