An Efficacy and Tolerance Comparison of Emedastine Difumarate 0.05% and Levocabastine Hydrochloride 0.05%: Reducing Chemosis and Eyelid Swelling in Subjects with Seasonal Allergic Conjunctivitis

Abstract

ABSTRACT.Purpose: To compare emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis. Methods: In a randomized, double-masked, parallel controlled study, emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model. Results: At Days 7, 14, 30 and 42, emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p∞0.05). A statistical trend was seen at Day 3 (0.05∞p∞0.10). Results were clinically relevant at Days 30 and 42. Emedastine was also significantly better at reducing redness and itching at Days 7, 14, 30 and 42 (p∞0.05). Conclusion: Emedastine is more efficacious than levocabastine in reducing chemosis, eyelid swelling and other efficacy variables associated with seasonal allergic conjunctivitis.

Management of Vernal Keratoconjunctivitis

“…Emedastine 0.05% appears to be more potent and selective than levocabastine [27, 28]. Indeed, in direct comparison with levocabastine, emedastine proved significantly more effective in alleviating signs of seasonal allergic conjunctivitis [27, 28].…”

“…Indeed, in direct comparison with levocabastine, emedastine proved significantly more effective in alleviating signs of seasonal allergic conjunctivitis [27, 28]. No specific studies in VKC have been performed.…”

Histamine-induced cytokine production and ICAM-1 expression in human conjunctival fibroblasts

“…[13][14] Topical histamine H-1 receptor antagonists (antiH-1) are considered the first-line drugs in the treatment of ocular allergic disorders due to their rapid effects on itching and redness. Emedastine, a new potent H-1 antagonist, 15 was shown to be effective in clinical practice [16][17] and to modulate in vitro cytokine production from conjunctival epithelial cells stimulated by histamine. 5 The aims of this study were first to evaluate whether conjunctival fibroblasts release proinflammatory cytokines or growth factors and express functional markers when stimulated with histamine, and second, to investigate the inhibitory capacities of H-1 and H-2 antagonists on these histamineinduced effects in cultured fibroblasts.…”

Emedastine difumarate: a review of its potential ameliorating effect for tissue remodeling in allergic diseases

“…However, topical immune suppressive agents, such as corticosteroids and ciclosporin, are used for more severe types, such as VKC. Many randomized, double-blinded, controlled clinical trials have demonstrated the efficacy of antihistamines in providing relief of many symptoms of allergic conjunctivitis (e.g., itching, redness, tearing, chemosis) [62][63][64][65][66][67][68][69][70][71][72]. One recent prospective, randomized, double-blinded, and placebo-controlled trial (n = 100) showed that 0.05% emedastine difumarate ophthalmic solution (twice per day) was significantly more effective than placebo, and similar to other ophthalmic solutions (olopatadine hydrochloride, ketotifen fumarate, epinastine hydrochloride) [62].…”