Evaluation of olopatadine, a new ophthalmic antiallergic agent with dual activity, using the conjunctival allergen challenge model.

BACKGROUND

An ophthalmic antiallergic agent with selective H1 antihistaminic and mast cell stabilizing properties has been developed.

OBJECTIVES

To evaluate efficacy and safety, determine optimal concentration, and demonstrate onset and duration of action of this new drug, olopatadine.

METHODS

This was a placebo-controlled, randomized, double-masked, parallel-group, single-center study with five outpatient visits at least 7 days apart. Ninety-eight healthy, allergy-positive, subjects with a recent history of active allergic conjunctivitis not receiving current treatment participated. Conjunctival allergen challenge (CAC) tests were performed on visits 1 and 2 to identify an allergen and concentration that consistently elicited signs and symptoms of allergic conjunctivitis. On visits 3, 4, and 5, CAC was performed 27 minutes, 8 hours, and 6 hours, respectively, after instillation of one drop of olopatadine (0.01%, 0.05%, 0.1%, or 0.15%) in one eye and placebo in the other. Both eyes were scored for the intensity of itching and redness at 3, 10, and 20 minutes after the CAC.

RESULTS

All four concentrations of olopatadine were clinically and statistically superior to placebo in preventing ocular itching at all evaluations and preventing redness at most evaluations from immediately and 8 hours after drug administration. No drug-related adverse events were reported. The 0.1% concentration was found to be most effective.

CONCLUSIONS

The results indicate that olopatadine ophthalmic solution is safe and effective in the treatment of allergic conjunctivitis, with the 0.1% concentration of olopatadine being optimal. The rapid onset and at least 8 hour duration of action of olopatadine indicates that the drug can be used twice daily.