title: Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies.
abstract: BACKGROUND
  We aimed to evaluate the safety and efficacy of loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.
  
  
  METHODS
  Patients with anterior chamber cell (ACC) inflammation ≥ grade 2 (6-15 cells) 1 day post-surgery were randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day instilled in the study eye 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 endpoints included adverse events (AEs), changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and funduscopy findings. Gel comfort was graded by patients according to drop sensation.
  
  
  RESULTS
  The intent-to-treat population included 813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P < 0.001 for both). Tolerability assessments for ocular itching, photophobia, and tearing favored LE gel 0.5% compared with vehicle at different time points beginning at Day 3. Two patients in the LE gel 0.5% group and 1 patient in the vehicle group exhibited a transient treatment-emergent increase in IOP ≥ 10 mmHg. Treatment-related AEs were generally mild to moderate and occurred less frequently with LE gel 0.5% than with vehicle. Reports of treatment-related blurred vision were rare (n = 2, vehicle).
  
  
  CONCLUSIONS
  LE gel 0.5% was efficacious and well tolerated in the treatment of postoperative pain and inflammation following ocular surgery, with minimal risk of IOP elevation.
authors.affiliation: See Clearly Vision Group, 8138 Watson Street, McLean, VA, 22102, USA, RRajpal@seeclearly.com.
authors.forename: Rajesh K
authors.initials: RK
authors.lastname: Rajpal
authors.forename: Raymond
authors.initials: R
authors.lastname: Fong
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Comstock
mesh_terms: D060433:Administration, Ophthalmic; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000627:therapeutic use*; D000867:Anterior Chamber; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002387:Cataract Extraction; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy; D011183:Postoperative Complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D005782:Gels; D000069559:Loteprednol Etabonate