Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model.
OBJECTIVE
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 Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01743027.
*Total Eye Care, PA, Memphis, TN; †Alcon Research Ltd, Fort Worth, TX; ‡Ora, Inc, Andover, MA; and §Andover Eye Associates, MA.
Eugene
E
McLaurin
Abhijit
A
Narvekar
Paul
P
Gomes
Adeniyi
A
Adewale
Gail
G
Torkildsen
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000009:adverse effects; D003233:Conjunctivitis, Allergic / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D000069605:Olopatadine Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D009883:Ophthalmic Solutions; D014677:Pharmaceutical Vehicles; D016896:Treatment Outcome; D014792:Visual Acuity; D055815:Young Adult
D000485:Allergens; D039563:Histamine H1 Antagonists, Non-Sedating; D009883:Ophthalmic Solutions; D014677:Pharmaceutical Vehicles; D000069605:Olopatadine Hydrochloride