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S.I. Frisch, H. Druce; Clinical Efficacy and Preference of Visine–A® and Patanol® in Preventing the Signs and Symptoms of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model . Invest. Ophthalmol. Vis. Sci. 2005;46(13):944.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate efficacy of Visine–A® as compared to Patanol® in prevention of the signs and symptoms of allergic conjunctivitis (AC) induced by the conjunctival allergen challenge (CAC) model and to determine subject preference using a forced choice query. Methods: This was a prospective, randomized, double–masked, contralateral, active and placebo–controlled study of asymptomatic subjects with a history of AC. In the CAC model, the allergen solution and dose required to elicit a positive allergic response were determined for each subject at visit 1 and confirmed at visit 2, with treatment evaluation taking place at visit 3. Subjects were randomized to receive one of the following at visit 3: Visine–A (Vis)/Patanol (P), Vis/Placebo (Pl) or P/Pl. CAC was performed 10 minsutes following instillation of masked study medication. Ocular itching, redness (conjunctival, ciliary, and episcleral), chemosis, and lid swelling assessments were taken at 7, 12, and 20 mins. post–CAC at visits 2 and 3. At the end of the visit, subjects were asked which eye treatment they preferred in terms of overall efficacy. Results: A total of 83 subjects completed this study. Both actives had lower mean itching scores than Pl (clinically and statistically significant at all time points). Vis had lower mean redness scores than Pl (clinically and statistically significant in all vessel beds at all 3 time points). P had lower mean redness scores than Pl (clinically significant in ciliary at 7 mins; statistically significant for all vessel beds at all time points). Both Vis and P had lower mean chemosis and lid swelling scores than Pl (p<0.05 at all time points). When compared to each other, there were no clinically significant differences in any parameter between Vis and P. Vis had lower mean redness scores (p<0.05 at 9/9 timepoints) and lower chemosis scores (p<0.05 at 2/3 time points) than P. P had a lower mean itching score (p<0.05 at 1/3 time points) than Vis. No statistically significant differences were seen between Vis and P in lid swelling scores. Most subjects (57.1%) in the Vis/P group preferred Vis. Conclusions: Visine–A was more effective than Patanol (at majority of assessments) and placebo in the prevention of the signs and symptoms of acute AC when administered 10 mins. prior to onset of the reaction. Efficacy data generated from the CAC model are generally recognized as the basis to support ocular allergy treatment indications.
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