Abstract

Volume.116 Number.12

Original article : Clinical science

A Multicenter, Double-masked, Randomized Evaluation of Olopatadine 0.2% Using the Conjunctival Allergen Challenge Model in Japanese Patients with Allergic Conjunctivitis
Shigeaki Ohno1; Olopatadine Study Group
1 Department of Ocular Inflammation and Immunology, Hokkaido University Graduate School of Medicine

Purpose: Olopatadine hydrochloride ophthalmic solution, 0.2% (olopatadine 0.2%) is approved for allergic conjunctivitis when instilled twice-daily. The objective of this study was to evaluate the efficacy and safety of olopatadine 0.2% (instilled twice-daily) versus vehicle and olopatadine 0.1% (instilled 4-times daily) in Japanese patients with allergic conjunctivitis.
Methods: A multicenter, parallel-group, double-masked, randomized, conjunctival allergen challenge (CAC) study. Patients≥18 years of age with histories of allergic conjunctivitis were treated with either olopatadine 0.2% or olopatadine 0.1% in a single eye and the vehicle in the contralateral eye at 1 visit.
Results: Overall, 267 patients were enrolled. Olopatadine 0.2% was superior to its vehicle for ocular itching (p<0.0001 at the time of observation) and marginally superior for total redness (p=0.0543 at the time of observation). Olopatadine 0.2% was similar to olopatadine 0.1% for ocular itching at the time of observation. No trends were identified through a review of safety parameters.
Conclusions: Olopatadine 0.2% (instilled twice-daily) is safe, well tolerated, superior to the vehicle, and similar to olopatadine 0.1% in preventing ocular itching. Olopatadine 0.2%, which can be instilled less often than olopatadine 0.1%, is a useful new option for allergic conjunctivitis in Japanese patients that could potentially result in better treatment compliance.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 116: 1123-1129, 2012.

Key words
Allergic Conjunctivitis, Olopatadine, Efficacy, Itching, Redness
Reprint requests to
Shigeaki Ohno, M.D., Ph.D. Department of Ocular Inflammation and Immunology, Hokkaido University Graduate School of Medicine. N-15, W-7 Kita-ku, Sapporo 060-8638, Japan