title: Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients.
abstract: BACKGROUND
  Seasonal allergic conjunctivitis (SAC) is caused by seasonal allergens and usually manifests as ocular itching and bulbar conjunctival injection (redness). Treatment options for SAC include corticosteroids and dual-acting antihistamine and mast-cell stabilizers.
  
  
  OBJECTIVE
  Our objective was to compare the efficacy and tolerability of loteprednol etabonate (LE), a C-20 ester-based corticosteroid, with those of olopatadine, a dual-acting antihistamine mast-cell stabilizer, in Chinese patients.
  
  
  METHODS
  This was a multicenter, randomized, investigator-masked, parallel group study. Patients with acute SAC experiencing grade 4 ocular itching and grade 2 or higher bulbar conjunctival injection received either LE suspension 0.2% QID at 4-hour intervals or olopatadine solution 0.1% BID at 6- to 8-hour intervals bilaterally for 15 days. Primary efficacy end points included the change from baseline (CFB) in ocular itching and bulbar conjunctival injection at day 15. The primary analysis tested the noninferiority of LE suspension 0.2% to olopatadine solution 0.1%. Tolerability outcomes included the incidence of adverse events (AEs), biomicroscopy findings, visual acuity, and intraocular pressure.
  
  
  RESULTS
  A total of 300 patients were randomly assigned, and 293 were included in the per-protocol population (LE, n = 147; olopatadine, n = 146). Mean (SD) CFB at day 15 in the LE and olopatadine treatment groups, respectively, was -3.74 (0.47) and -3.28 (0.91) for ocular itching and -1.91 (0.52) and -1.71 (0.59) for bulbar conjunctival injection. The 95% CI for the differences in CFB in ocular itching (-0.59 to -0.27) and bulbar conjunctival injection (-0.27 to -0.08) was less than the prespecified noninferiority limit of 0.3. Treatment differences in CFB were significantly better with LE compared with olopatadine for both end points (P ≤ 0.0006). Ocular AEs were few and similar between treatment groups. There were no clinically significant biomicroscopy or visual acuity findings, and no patient experienced a clinically significant increase in intraocular pressure (≥10 mm Hg).
  
  
  CONCLUSIONS
  Results of this investigator-masked study with Chinese patients suggest LE suspension 0.2% was noninferior to olopatadine solution 0.1% for the treatment of SAC. Both LE suspension 0.2% and olopatadine solution 0.1% were well tolerated. ClinicalTrials.gov identifier: NCT01435460.
authors.affiliation: EYE and ENT Hospital of Fundan University, Shanghai, China. gong_lan70@yahoo.com.cn
authors.forename: Lan
authors.initials: L
authors.lastname: Gong
authors.forename: Xinghuai
authors.initials: X
authors.lastname: Sun
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: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Linnong
authors.initials: L
authors.lastname: Wang
authors.forename: Yangshun
authors.initials: Y
authors.lastname: Gu
authors.forename: Albert
authors.initials: A
authors.lastname: Elion-Mboussa
authors.forename: Lipika
authors.initials: L
authors.lastname: Roy
authors.forename: Byron
authors.initials: B
authors.lastname: Zhu
mesh_terms: D060433:Administration, Ophthalmic; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D003990:Dibenzoxepins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D000069559:Loteprednol Etabonate; D000069605:Olopatadine Hydrochloride
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D000069605:Olopatadine Hydrochloride; D000069559:Loteprednol Etabonate