Olopatadine hydrochloride ophthalmic solution 0.2% (Pataday, Alcon) is a new formulation of
olopatadine hydrochloride ophthalmic solution, the first topical ocular
antiallergic agent indicated for once-daily dosing. The aim of this study was to evaluate the safety, efficacy, onset, and duration of action of
olopatadine 0.2% in the treatment of
allergic conjunctivitis. Using the conjunctival
allergen challenge, this double-masked, randomized by eye, parallel-group study included four visits over a 5-week period. Subjects were screened for eligibility (visit 1) and their ocular allergic responses were confirmed at visit 2. The efficacy of
olopatadine in reducing the signs and symptoms of
allergic conjunctivitis was evaluated at onset of action (visit 4) and 16 hours (visit 3) after masked medication instillation. The primary efficacy parameter was ocular
itching. Safety parameters were also evaluated. Ninety subjects were evaluated.
Olopatadine 0.2% was significantly (p < 0.001) more effective than placebo in the treatment of ocular
itching at all time points at both the onset of action and the 16-hour
allergen challenges.
Olopatadine 0.2% was significantly (p < 0.03) more effective than placebo in the reduction of conjunctival redness, chemosis, and eyelid swelling at all time points (with the exception of conjunctival redness, which was significantly reduced at five of six time points). There were no serious adverse events and no treatment-related adverse events. Once-daily dosing with
olopatadine 0.2% reduced the signs and symptoms of
allergic conjunctivitis with a rapid and prolonged duration of action. Safety analyses indicated that
olopatadine 0.2% was safe and well tolerated in subjects with a history of
allergic conjunctivitis.