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M. B. Abelson, M. R. Edwards, C. Vogelson, T. Pasquine, S. M. Robertson; Effects of Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (patadayTM) on the Ocular Itching and Redness Associated With Allergic Conjunctivitis or Rhinoconjunctivitis. Invest. Ophthalmol. Vis. Sci. 2008;49(13):414.
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To evaluate the safety and efficacy of olopatadine HCl ophthalmic solution, 0.2% (OLO) in the treatment of ocular itching and redness associated with allergic conjunctivitis or rhinoconjunctivitis using an environmental study design.
This was a 6-week, multi-center, randomized (1:1), parallel group, double-masked comparison of OLO versus vehicle in subjects 10 years of age and older who had histories of seasonal allergic conjunctivitis, positive skin tests for grass, and positive bilateral ocular responses to grass pollen as elicited by a conjunctival allergen challenge. During the study, subjects dosed once daily and evaluated their ocular itching and redness three times each day (morning, mid-day, evening) in a diary. Grass pollen levels were monitored throughout the study, subject enrollment was coordinated around the historical pollen season in each geographic location, and efficacy was based upon the 14 consecutive days of peak pollen at each site.
287 patients were randomized to treatment. The average daily diary scores over the peak pollen period for itching and redness were statistically lower for the OLO group than for the vehicle group at all three time-points (p≤0.0204 for mean evaluations of itching at all time-points, and p≤0.0378 for mean evaluations of redness at all time-points). No safety issues were identified and subject use of contact lenses did not alter the safety profile.
Once-daily olopatadine HCl ophthalmic solution, 0.2% significantly reduced ocular itching and redness throughout the day in patients with allergic conjunctivitis or rhinoconjunctivitis.
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