title: [A 10-week safety and efficacy evaluation of olopatadine, 0.2% instilled twice-daily in patients with allergic conjunctivitis in Japan].
abstract: OBJECTIVE
  Olopatadine hydrochloride ophthalmic solution, 0.2% (olopatadine 0.2%) is a multi-action agent approved in Japan for allergic conjunctivitis when used as a dose of 1 to 2 drops twice-daily. The objective of this study was to evaluate the long-term (10 weeks) safety and efficacy of olopatadine 0.2% in Japanese patients with allergic conjunctivitis when used as a dose of 2 drops twice-daily.
  
  
  METHODS
  This was a single-insititution, open-label, single-group study of symptomatic patients > or = 12 years of age with allergic conjunctivitis.
  
  
  RESULTS
  A total of 110 Japanese patients were enrolled. From baseline to week 10, the mean (95% confidence interval) absolute changes were -2.4 (-2.7, -2.2) in ocular itching and the total hyperemia scores were -3.2 (-3.4, -2.9). Mean scores for all other efficacy variables were low at baseline (< or = 2.4) and decreased to < or = 0.6 by week 10. There were no serious adverse events. Mild eye irritation (1 patient) was the only treatment-related event. No safety concerns were identified in a review of the safety results.
  
  
  CONCLUSIONS
  Based on this study, olopatadine 0.2% is generally safe, well tolerated and effective when instilled as 2 drops in both eyes twice-daily in Japanese patients with allergic conjunctivitis and is a useful new option for ocular allergy management.
authors.affiliation: Department of Ocular Inflammation and Immunology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. sohno@med.hokudai.ac.jp
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Ohno
authors.forename: Makoto
authors.initials: M
authors.lastname: Ando
mesh_terms: D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D003990:Dibenzoxepins / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007322:Instillation, Drug; D007564:Japan; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride
chemical_list: D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D000069605:Olopatadine Hydrochloride