title: Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery.
  
  
  METHODS
  Twenty centers in the United States and the Netherlands.
  
  
  METHODS
  Prospective randomized clinical trials.
  
  
  METHODS
  Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted.
  
  
  RESULTS
  The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups.
  
  
  CONCLUSIONS
  In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain.
  
  
  BACKGROUND
  Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Hovanesian
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Sheppard
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: William B
authors.initials: WB
authors.lastname: Trattler
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: Johnny L
authors.initials: JL
authors.lastname: Gayton
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: Ranjan P
authors.initials: RP
authors.lastname: Malhotra
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA. Electronic address: dschaaf@omeros.com.
authors.forename: David T
authors.initials: DT
authors.lastname: Schaaf
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: Edmund
authors.initials: E
authors.lastname: Ng
authors.affiliation: From Harvard Eye Associates (Hovanesian), Orange County, California, Virginia Eye Consultants (Sheppard), Norfolk, Virginia, Center for Excellence in Eye Care (Trattler), Miami, Florida, Eyesight Associates, Warner Robins and Mercer Medical School (Gayton), Macon, Georgia, Ophthalmology Associates (Malhotra), St. Louis, Missouri, Omeros Corporation (Schaaf), Seattle, and Pacific Northwest Statistical Consulting (Ng), Woodinville, Washington, and Houston Eye Associates (Dunn), Houston, Texas, USA.
authors.forename: Steven H
authors.initials: SH
authors.lastname: Dunn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000867:Anterior Chamber / Q000187:drug effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D058447:Eye Pain / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009184:Mydriatics / Q000008:administration & dosage / Q000009:adverse effects; D009883:Ophthalmic Solutions; D010149:Postoperative Pain / Q000517:prevention & control*; D018918:Phacoemulsification; D010656:Phenylephrine / Q000008:administration & dosage* / Q000009:adverse effects; D011680:Pupil / Q000187:drug effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D009184:Mydriatics; D009883:Ophthalmic Solutions; D010656:Phenylephrine; D020910:Ketorolac