Abstract

To study the safety and efficacy of the topical corticosteroid, desonide 0.25% ophthalmic solution, for inhibition of the clinical allergic reaction induced by conjunctival provocation (CPT) and for the treatment of seasonal allergic conjunctivitis (SAC). For the CPT study, 12 allergic but inactive patients were exposed in both eyes to increasing doses of a specific allergen until a positive bilateral, symmetrical early- and late-phase reaction was obtained. After 2 weeks the last positive dose was readministrated and their positive response confirmed. After an additional 2 weeks, CPT was performed 30 minutes after topical administration of desonide in one eye and placebo in the contralateral eye (Group A) or after topical desonide or placebo four times a day for 2 days (Group B). Clinical signs and symptoms were recorded after 15, 30, and 60 minutes, and after 6 hours. Regarding the seasonal study, 96 patients with active SAC were treated bilaterally with either desonide or fluorometholone for 3 weeks, and allergic signs and symptoms evaluated at regular intervals. The safety of the drugs was assessed by identification of any side effects or adverse events of any kind. For the CPT study: individual itching and redness, and the sum score for signs and symptoms were all statistically (p < 0.05) and clinically (greater than 1 change between treated eyes) significantly lower in desonide versus placebo eyes. Both early- and late-phase reactions were reduced by desonide pretreatment. Seasonal study: desonide and fluorometholone were both highly effective in reducing itching, tearing, and conjunctival hyperemia over time (p < 0.0001). Both drugs appeared safe, with no statistically significant changes in IOP observed with either treatment. Desonide has a significant therapeutic effect on both the induced conjunctival early- and late-allergic reaction and in active SAC. It was also safe, with no side effects such as increases in intraocular pressure observed by physician or patient.

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