Document Detail


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.
MedLine Citation:
PMID:  22627057     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Lan Gong; Xinghuai Sun; Jia Qu; Lili Wang; Mingzhi Zhang; Hong Zhang; Linnong Wang; Yangshun Gu; Albert Elion-Mboussa; Lipika Roy; Byron Zhu
Related Documents :
17052307 - Long-term effect of bronchial artery embolization in korean patients with haemoptysis.
11012707 - Cardiac tamponade due to post-cardiac injury syndrome in a patient with severe haemophi...
20590857 - Clinical issues in inhibitors.
17007647 - Endovascular control of haemorrhagic urological emergencies: an observational study.
12719047 - Sevoflurane requirements during coloproctologic surgery: difference between two differe...
22090167 - Colchicine reduces postoperative atrial fibrillation: results of the colchicine for the...
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-22
Journal Detail:
Title:  Clinical therapeutics     Volume:  -     ISSN:  1879-114X     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7706726     Medline TA:  Clin Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.
Affiliation:
EYE and ENT Hospital of Fundan University, Shanghai, China.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Pediatric keratocystic odontogenic tumor and nevoid basal cell carcinoma syndrome. Predictive factor...
Next Document:  A novel compound heterozygous TACI mutation in an autosomal recessive Common Variable Immunodeficien...