Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution in Children and Adolescents: An 8-Week Phase 3 Study
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND AND OBJECTIVE: Preservative- and phosphate-free bilastine ophthalmic solution with sodium hyaluronate provides additional benefits for ocular surface protection and hydration compared with second-generation antihistamines. These advantages are especially relevant for long-term pediatric treatment, although no previous study has evaluated the safety of the solution in this population. Objective: To evaluate the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in children and adolescents with allergic conjunctivitis. METHODS: This multicenter, randomized, double blind, placebo-controlled, parallel-group, phase 3 study included patients aged >2 to <18 years who were randomized 2:1 to receive bilastine or placebo for 8 weeks. The primary endpoint was the incidence of ocular-related treatment-emergent adverse events (ocular r-TEAEs). RESULTS: Sixty-five patients were enrolled, and 59 were randomized: 42 to bilastine and 17 to placebo. No ocular r-TEAEs occurred in bilastine-treated patients (0/42 [95%CI, 0.0%-8.4%]), while 1 was reported in a placebo-treated patient (1/17 [95%CI, 1.1%-27.0%]). The overall incidence of ocular TEAEs was similar in both groups (bilastine 16.7% [95%CI, 8.3%-30.6%]; 7/42; placebo 17.6% [95%CI, 6.2%-41.0%]; 3/17). No serious or severe TEAEs occurred. Moderate TEAEs were reported in 4.8% (2/42, 95%CI, 1.3%-15.8%) of bilastine patients and 5.9% (1/17, 95%CI, 1.1-27.0%) of placebo patients. Most participants reported no or only slight ocular symptoms or discomfort after instillation, both at baseline and after 8 weeks. CONCLUSIONS: Preservative- and phosphate-free bilastine 0.6% ophthalmic solution with sodium hyaluronate was safe and well-tolerated in pediatric patients aged >2 years after a once-daily, 8-week treatment, with a safety profile comparable to that of placebo.
DOI: 10.18176/jiaci.1169
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7141610311
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