Safety and Efficacy Comparison of Emedastine 0.05% Ophthalmic Solution Compared to Levocabastine 0.05% Ophthalmic Suspension in Pediatric Subjects with Allergic Conjunctivitis

Abstract

ABSTRACT.Purpose: To determine the efficacy and tolerance of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects. Methods and Materials: In a randomized, double-masked, parallel controlled study, emedastine 0.05% ophthalmic solution BID was compared to levocabastine 0.05% ophthalmic suspension BID, for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3-16. Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A diary was completed by the parents four times daily for the first two and last two weeks of the study. Treatment lasted 42 days. Drug efficacy was assessed at the initial administration in the office at Day 0 and after 3, 7, 14, 30 and 42 days.

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.…”

Antihistamines in Ocular Allergy: Are They All Created Equal?

“…Studies in patients with AC showed that it provided significantly more relief of itching and hyperemia than placebo at a duration of at least 4 hours [26]. Emedastine also had the advantage of being approved for use in patients 3 years of age or older [27]. With these findings, the evolution of the dual-acting molecules had begun.…”

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].…”