title: Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular inflammation and pain after cataract surgery: phase 3 study.
abstract: OBJECTIVE
  To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery.
  
  
  METHODS
  Sixty-five centers in the United States and Europe.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: 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.
authors.forename: Satish S
authors.initials: SS
authors.lastname: Modi
authors.affiliation: 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.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Lehmann
authors.affiliation: 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.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Walters
authors.affiliation: 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.
authors.forename: Raymond
authors.initials: R
authors.lastname: Fong
authors.affiliation: 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.
authors.forename: William C
authors.initials: WC
authors.lastname: Christie
authors.affiliation: 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.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Roel
authors.affiliation: 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.
authors.forename: David
authors.initials: D
authors.lastname: Nethery
authors.affiliation: 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.
authors.forename: Dana
authors.initials: D
authors.lastname: Sager
authors.affiliation: 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.
authors.forename: Alexis
authors.initials: A
authors.lastname: Tsorbatzoglou
authors.affiliation: 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.
authors.forename: Bo
authors.initials: B
authors.lastname: Philipson
authors.affiliation: 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.
authors.forename: Carlo E
authors.initials: CE
authors.lastname: Traverso
authors.affiliation: 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.
authors.forename: Harvey
authors.initials: H
authors.lastname: Reiser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D044482:Benzeneacetamides / Q000008:administration & dosage*; D004311:Double-Blind Method; D009877:Endophthalmitis / Q000517:prevention & control*; D058447:Eye Pain / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D010648:Phenylacetates / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D009883:Ophthalmic Solutions; D010648:Phenylacetates; C414203:nepafenac