Journal
CORNEA
Volume 34, Issue 10, Pages 1245-1251Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/ICO.0000000000000562
Keywords
antihistamine; allergic conjunctivitis; conjunctival allergen challenge model; once-daily olopatadine; ocular itching
Categories
Funding
- Aciex
- Acucela
- Alcon Research Ltd
- Allergan
- AstraZeneca
- Bausch Lomb
- Inotek Pharma
- InSite Vision
- Lexicon Pharma
- Mimetogen
- Ocular Therapeutix
- Ora, Inc
- Alcon Research Ltd.
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Purpose:To assess the efficacy and safety of a novel once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis (AC) using the conjunctival allergen challenge (CAC) model.Methods:In this 5-week, multicenter, double-masked, phase 3, randomized trial, subjects aged 18 years with a history of AC and a confirmed positive bilateral CAC response were randomized 2:2:2:1 to receive olopatadine 0.77%, olopatadine 0.2%, olopatadine 0.1%, or vehicle, respectively, following a single topical dose in each eye. The primary objective was superiority of olopatadine 0.77% over all comparators on ocular itching according to a 0 to 4 scale (0 = none and 4 = incapacitating itch) at 24-hour duration of action and over vehicle only at the onset of action (3, 5, and 7 minutes after CAC for both).Results:In total, 345 subjects were randomized. Olopatadine 0.77% was superior to the vehicle at alleviating ocular itching at all post-CAC time points at the onset of action and at 24 hours (difference in means: -0.9 to -1.5; P < 0.0001). Superiority in relieving ocular itching was also demonstrated for olopatadine 0.77% versus olopatadine 0.2% and 0.1% at 24 hours (difference in means: -0.3 to -0.5; P < 0.05). Additionally, olopatadine 0.77% significantly improved conjunctival redness and total redness compared with all comparators at the onset of action (differences in means: -0.3 to -0.6 and -0.8 to -2.0, respectively; both P < 0.05). No safety concerns for olopatadine 0.77% were identified.Conclusions:Olopatadine 0.77% demonstrated a rapid onset and prolonged duration of action. It was superior to all comparators in alleviating AC-associated ocular itching with a favorable safety profile.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01743027.
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