Phase 3 Study of Efficacy and Safety of Once-daily Olopatadine Hydrochloride, 0.77% Ophthalmic Formulation in Patients With Allergic Conjunctivitis Using the Ora Conjunctival Allergen Challenge Model (Ora-CAC™*) (NCT01743027)

Abstract

 

Purpose

 

To assess the efficacy and safety of a new, once-daily olopatadine 0.77% formulation compared with olopatadine 0.2%, olopatadine 0.1%, or vehicle for the treatment of allergic conjunctivitis.

 

Methods

 

This multicenter, double-blind, parallel-group, vehicle- and active-controlled study randomized patients with a history of allergic conjunctivitis (N=345; ≥18 years) 2:2:2:1 to olopatadine 0.77% (n=98), olopatadine 0.2% (n=99), olopatadine 0.1% (n=99), or vehicle (n=49). The primary endpoint was ocular itching (OI; at 3, 5 and 7 minutes post-CAC) at onset of action and 24-hours duration of action for olopatadine 0.77% versus vehicle, and OI at 24-hours duration of action for olopatadine 0.77% versus olopatadine 0.2% or olopatadine 0.1%.

 

Results

 

Olopatadine 0.77% was superior (p<0.0001) to vehicle for OI at all post-CAC time-points at onset and 24-hours duration of action. Differences in means (olopatadine 0.77% - vehicle) were: -1.53, -1.46, -1.17 (onset) and -1.29, -1.15, -0.89 (24 hours) for olopatadine 0.77% at 3, 5 and 7 minutes post-CAC, respectively. Olopatadine 0.77% was also superior to olopatadine 0.1% for the treatment of OI at 24-hours duration of action at all post-CAC time points, and superior to olopatadine 0.2% at 3 and 5 minutes post-CAC (Table 1). There were no clinically relevant changes in safety parameters from baseline across the treatment groups, and a review of adverse events did not reveal any safety issues for olopatadine 0.77%.

 

Conclusions

 

Olopatadine 0.77% was superior to vehicle, olopatadine 0.1% and olopatadine 0.2% with respect to reduction of OI associated with allergic conjunctivitis 24 hours after dosing. Olopatadine 0.77% had a safety profile comparable to olopatadine 0.1% and olopatadine 0.2%. The superior efficacy at 24 hours of olopatadine 0.77% supports potential once-daily administration and a longer duration of symptom relief compared with olopatadine 0.1% and olopatadine 0.2%. *Ora-CAC™ and Ora Calibra™ are trademarks of Ora, Inc. The Ora Conjunctival Allergen Challenge Model and Ocular Itching Scale are owned by Ora, Inc.

 

 

Keywords: 475 conjunctivitis • 557 inflammation • 555 immunomodulation/immunoregulation