{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T13:07:57Z","timestamp":1774616877736,"version":"3.50.1"},"reference-count":0,"publisher":"Esmon Publicidad, SA","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Investig Allergol Clin Immunol"],"abstract":"<jats:p>Background: 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.\nObjective: 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.\nMethods: This multicenter, randomized, double blind, placebo-controlled, parallel-group, phase 3 study included patients aged &gt;2 to &lt;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).\nResults: 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.\nConclusions: Preservative- and phosphate-free bilastine 0.6% ophthalmic solution with sodium hyaluronate was safe and well-tolerated in pediatric patients aged &gt;2 years after a once-daily, 8-week treatment, with a safety profile comparable to that of placebo.<\/jats:p>","DOI":"10.18176\/jiaci.1169","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T12:22:12Z","timestamp":1774614132000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution in Children and Adolescents: An 8-Week Phase 3 Study"],"prefix":"10.18176","volume":"37","author":[{"given":"Teresa","family":"Garriga-Baraut","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clara","family":"Padr\u00f3-Casas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adelaida","family":"S\u00e1nchez Bacallao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pablo","family":"Dur\u00e1n-P\u00e9rez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eva","family":"Lasa Luaces","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Porfirio","family":"Fern\u00e1ndez Gonz\u00e1lez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amalia","family":"Leceta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Mart\u00ednez Ostal\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inmaculada","family":"Gilaberte","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7491","published-online":{"date-parts":[[2026,3,27]]},"container-title":["Journal of Investigational Allergology and Clinical Immunology"],"original-title":[],"deposited":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T12:22:12Z","timestamp":1774614132000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jiaci.org\/ahead-of-print\/safety-and-tolerability-of-bilastine-0-6--ophthalmic-solution-in-children-and-adolescents--an-8-week-phase-3-study\/supp"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,27]]},"references-count":0,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3,27]]}},"URL":"https:\/\/doi.org\/10.18176\/jiaci.1169","relation":{},"ISSN":["1018-9068","1698-0808"],"issn-type":[{"value":"1018-9068","type":"print"},{"value":"1698-0808","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,27]]}}}