title: Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery.
abstract: OBJECTIVE
  To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery.
  
  
  METHODS
  Seventeen United States clinical sites.
  
  
  METHODS
  Prospective double-masked parallel-group study.
  
  
  METHODS
  Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomized to loteprednol etabonate 0.5% gel or vehicle 4 times a day for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative day 8. Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort).
  
  
  RESULTS
  The intent-to-treat population included 406 patients (203 per treatment). On day 8, 30.5% of patients in the loteprednol etabonate group and 16.3% of patients in the vehicle group had complete resolution of ACC, whereas 72.9% and 41.9%, respectively, had grade 0 pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade 0 pain favoring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥ 10 mm Hg). Analyses of pain, photophobia, and tearing favored loteprednol etabonate at different time points beginning on day 3. More than 85% of patients in each treatment group reported no discomfort on drop instillation.
  
  
  CONCLUSIONS
  Loteprednol etabonate gel 0.5% was efficacious and safe in treating postoperative inflammation and pain.
  
  
  BACKGROUND
  Dr. Rajpal is a consultant to Bausch & Lomb, Inc., Allergan, Inc., and Alcon Laboratories, Inc. Dr. Siou-Mermet and Ms. Erb are employees of Bausch & Lomb, Inc. Dr. Roel has no financial or proprietary interest in any material or method mentioned.
authors.affiliation: See Clearly Vision Group, McLean, Virginia 22102, USA. rrajpal@seeclearly.com
authors.forename: Rajesh K
authors.initials: RK
authors.lastname: Rajpal
authors.forename: Lawrence
authors.initials: L
authors.lastname: Roel
authors.forename: Raphaele
authors.initials: R
authors.lastname: Siou-Mermet
authors.forename: Tara
authors.initials: T
authors.lastname: Erb
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D000867:Anterior Chamber / Q000473:pathology; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002387:Cataract Extraction; D004311:Double-Blind Method; D058447:Eye Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005782:Gels; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000209:etiology; D007429:Intraocular Pressure; D000069559:Loteprednol Etabonate; D008297:Male; D033401:Microscopy, Acoustic; D008875:Middle Aged; D019721:Ophthalmoscopes; D011183:Postoperative Complications; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology; D014792:Visual Acuity
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D005782:Gels; D000069559:Loteprednol Etabonate