PMID- 22627057
OWN - NLM
STAT- MEDLINE
DCOM- 20121011
LR  - 20160623
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 34
IP  - 6
DP  - 2012 Jun
TI  - 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.
PG  - 1259-1272.e1
LID - 10.1016/j.clinthera.2012.04.024 [doi]
AB  - 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). CONCLUSION: 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.
CI  - Copyright (c) 2012 Elsevier HS Journals, Inc. All rights reserved.
FAU - Gong, Lan
AU  - Gong L
AD  - EYE and ENT Hospital of Fundan University, Shanghai, China. 
      gong_lan70@yahoo.com.cn
FAU - Sun, Xinghuai
AU  - Sun X
FAU - Qu, Jia
AU  - Qu J
FAU - Wang, Lili
AU  - Wang L
FAU - Zhang, Mingzhi
AU  - Zhang M
FAU - Zhang, Hong
AU  - Zhang H
FAU - Wang, Linnong
AU  - Wang L
FAU - Gu, Yangshun
AU  - Gu Y
FAU - Elion-Mboussa, Albert
AU  - Elion-Mboussa A
FAU - Roy, Lipika
AU  - Roy L
FAU - Zhu, Byron
AU  - Zhu B
LA  - eng
SI  - ClinicalTrials.gov/NCT01435460
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120523
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Dibenzoxepins)
RN  - 2XG66W44KF (Olopatadine Hydrochloride)
RN  - YEH1EZ96K6 (Loteprednol Etabonate)
SB  - IM
MH  - Administration, Ophthalmic
MH  - Adult
MH  - Androstadienes/administration & dosage/adverse effects/*therapeutic use
MH  - Anti-Allergic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - China
MH  - Conjunctivitis, Allergic/*drug therapy
MH  - Dibenzoxepins/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Humans
MH  - Loteprednol Etabonate
MH  - Olopatadine Hydrochloride
EDAT- 2012/05/26 06:00
MHDA- 2012/10/12 06:00
CRDT- 2012/05/26 06:00
PHST- 2012/02/07 00:00 [received]
PHST- 2012/04/24 00:00 [revised]
PHST- 2012/04/25 00:00 [accepted]
PHST- 2012/05/26 06:00 [entrez]
PHST- 2012/05/26 06:00 [pubmed]
PHST- 2012/10/12 06:00 [medline]
AID - S0149-2918(12)00288-3 [pii]
AID - 10.1016/j.clinthera.2012.04.024 [doi]
PST - ppublish
SO  - Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. 
      Epub 2012 May 23.