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Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution in Children and Adolescents: An 8-Week Phase 3 Study
Teresa Garriga-Baraut1, Clara Padró-Casas2, Adelaida Sánchez Bacallao3
1Pediatric Allergy Department, Vall D´Hebron University Hospital, Growth and Development Research Group, Vall d´Hebron Research Institute (VHIR), Barcelona, Spain.
Insights
Preservative-free bilastine ophthalmic solution is safe and well-tolerated for children with allergic conjunctivitis. The study found no ocular adverse events in the bilastine group, demonstrating a comparable safety profile to placebo.
Area of Science:
- Ophthalmology
- Allergology
- Pediatric Medicine
Background:
- Bilastine ophthalmic solution, free of preservatives and phosphates and containing sodium hyaluronate, offers enhanced ocular surface protection and hydration.
- These benefits are particularly significant for long-term pediatric treatment of allergic conjunctivitis.
- Previous studies have not assessed the safety of this specific ophthalmic solution in pediatric populations.
Purpose of the Study:
- To evaluate the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution.
- The evaluation focused on children and adolescents diagnosed with allergic conjunctivitis.
- Treatment involved once-daily administration for a duration of 8 weeks.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 clinical trial was conducted.
- Participants included patients aged greater than 2 years and less than 18 years.
- Patients were randomized in a 2:1 ratio to receive either bilastine or a placebo for 8 weeks, with ocular-related treatment-emergent adverse events (r-TEAEs) as the primary endpoint.
Main Results:
- A total of 65 patients were enrolled, with 59 randomized (42 to bilastine, 17 to placebo).
- No ocular r-TEAEs were reported in the bilastine group (0/42), compared to one in the placebo group (1/17).
- The overall incidence of ocular treatment-emergent adverse events (TEAEs) was similar between groups (16.7% bilastine vs. 17.6% placebo), with no serious or severe events. Moderate TEAEs were infrequent and comparable across groups.
Conclusions:
- Preservative- and phosphate-free bilastine 0.6% ophthalmic solution with sodium hyaluronate demonstrated safety and good tolerability in pediatric patients over 2 years old.
- The safety profile was comparable to placebo after 8 weeks of once-daily treatment.
- The findings support the use of this ophthalmic solution for long-term pediatric allergic conjunctivitis management.
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.
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