title: A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis.
abstract: OBJECTIVE
  To compare the efficacy and safety of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in a Chinese population with ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
  
  
  METHODS
  This study was a multicenter, randomized, investigator-masked, parallel-group clinical trial. Patients aged ≥18 years with a clinical diagnosis of BKC in at least one eye received LE/T or DM/T administered 4 times daily for 2 weeks. At baseline and on days 3, 8, and 15 (visits 2, 3, and 4), clinical assessments of ocular signs and symptoms, visual acuity (VA), biomicroscopy, and intraocular pressure (IOP) were performed in both eyes.
  
  
  METHODS
  The primary efficacy endpoint was the change from baseline (CFB) to visit 4 in the signs and symptoms composite score in designated study eyes using a non-inferiority metric to compare LE/T to DM/T. Safety evaluation included adverse events, biomicroscopy findings, and changes in VA and IOP.
  
  
  BACKGROUND
  NCT number, NCT01028027.
  
  
  RESULTS
  A total of 308 patients were included in the per protocol population (n = 156 LE/T, n = 152 DM/T). A significant CFB in composite signs and symptoms was seen with both treatments at each follow-up visit (p < 0.0001). The mean (SD) CFB at visit 4 was -11.63 (4.56) and -12.41 (4.71) in the LE/T and DM/T groups, respectively, and the upper bound of the 90% confidence interval for the difference was less than the prespecified non-inferiority margin. Comparable results were found for secondary efficacy outcomes. Patients treated with DM/T experienced a significantly greater increase in mean CFB in IOP compared to those treated with LE/T at all follow-up visits (p ≤ 0.0186) and nearly twice as many IOP elevations ≥5 mmHg (p = 0.0020).
  
  
  CONCLUSIONS
  Treatment with LE/T was at least as effective as DM/T in Chinese patients with BKC and had a better safety profile with respect to change in IOP.
authors.affiliation: Eye and ENT Hospital of Fudan University  ,   Shanghai  ,   China.
authors.forename: Minjie
authors.initials: M
authors.lastname: Chen
authors.forename: Lan
authors.initials: L
authors.lastname: Gong
authors.forename: Xinghuai
authors.initials: X
authors.lastname: Sun
authors.forename: Yangshun
authors.initials: Y
authors.lastname: Gu
authors.forename: Xiangge
authors.initials: X
authors.lastname: He
authors.forename: Jia
authors.initials: J
authors.lastname: Qu
authors.forename: Lili
authors.initials: L
authors.lastname: Wang
authors.forename: Mingzhi
authors.initials: M
authors.lastname: Zhang
authors.forename: Xingwu
authors.initials: X
authors.lastname: Zhong
mesh_terms: D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D044466:Asian People; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D007637:Keratoconjunctivitis / Q000188:drug therapy*; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000900:Anti-Bacterial Agents; D003907:Dexamethasone; D014031:Tobramycin; D000069559:Loteprednol Etabonate