Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial

Abstract

Purpose: The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.

Study design: This was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20-65 years) with seasonal allergic conjunctivitis in Japan.

Methods: The left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~ 30 mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24 h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).

Results: In total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means ± standard error, - 1.12 ± 0.214; p < 0.0001) and mean conjunctival hyperaemia scores (- 0.54 ± 0.197; p = 0.0097) 24 h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.

Conclusion: With its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.

Keywords: Allergic conjunctivitis; Conjunctival hyperaemia; Epinastine; Ocular itching; Ophthalmic cream.

Fig. 1

Design of the clinical trial, showing patient visits and treatment periods. CAC, conjunctival allergen challenge; IgE, immunoglobulin E

Fig. 2

Flow chart of patient populations. ITT, intent-to-treat

Fig. 3

Antigen challenge data showing mean (a) ocular itching scores and (b) conjunctival hyperaemia scores of epinastine-treated eyes and placebo-treated eyes. The filled circles and empty circles represent the scores measured at each time point for epinastine-treated eyes and placebo-treated eyes, respectively. The graphs to the right in panels (a) and (b) with the filled squares represent the mean difference between the scores measured at each time point for epinastine-treated eyes and placebo-treated eyes. CI, confidence interval; SD, standard deviation

Fig. 4

Antigen challenge data showing mean (a) bulbar conjunctival hyperaemia scores and (b) palpebral conjunctival hyperaemia scores of epinastine-treated eyes and placebo-treated eyes. The filled circles and empty circles represent the scores measured at each time point for epinastine-treated eyes and placebo-treated eyes, respectively. The graphs to the right in panels (a) and (b) with filled squares represent the mean difference between the scores measured at each time point for epinastine-treated eyes and placebo-treated eyes. CI, confidence interval; SD, standard deviation