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Combination of 0.05% Azelastine and 0.1% Tacrolimus Eye Drops in Children With Vernal Keratoconjunctivitis: A
Minjie Chen1,2,3,4, Anji Wei1,2,3,4, Bilian Ke5
1Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.
Insights
Combination eye drops of azelastine and tacrolimus offer faster relief for pediatric vernal keratoconjunctivitis (VKC) than tacrolimus alone. This combination therapy significantly improves VKC symptoms and clinical signs in children.
Area of Science:
- Ophthalmology
- Pediatric Allergy & Immunology
Background:
- Vernal keratoconjunctivitis (VKC) is a severe allergic eye disease affecting children.
- Current treatments for VKC, such as topical corticosteroids, have potential side effects.
- Tacrolimus is an effective immunomodulator for VKC, but its efficacy can be enhanced.
Purpose of the Study:
- To compare the efficacy of combined 0.05% azelastine and 0.1% tacrolimus eye drops versus 0.1% tacrolimus monotherapy.
- To evaluate treatment outcomes in pediatric patients diagnosed with VKC.
- To assess improvements in ocular surface disease index (OSDI) and clinical signs of VKC.
Main Methods:
- A prospective randomized controlled trial involving 76 pediatric VKC patients.
- Patients were assigned to either 0.1% tacrolimus monotherapy or a combination of 0.05% azelastine and 0.1% tacrolimus.
- Ocular assessments included OSDI scores, conjunctival hyperemia, corneal involvement, and papillae at baseline and at 1, 2, and 6 weeks.
Main Results:
- Both treatment groups showed significant improvements in OSDI scores and clinical VKC signs (p < 0.001).
- The combination therapy group demonstrated a significantly greater reduction in OSDI scores at 1 week (p=0.0085).
- Combination therapy led to superior improvements in conjunctival hyperemia and papillae (p < 0.05) and reduced corneal involvement at 2 weeks (p=0.0488) compared to monotherapy.
Conclusions:
- The combination of 0.05% azelastine and 0.1% tacrolimus eye drops provides faster and more significant clinical improvements in pediatric VKC.
- This combination therapy is a promising alternative for managing VKC in children, offering enhanced efficacy over tacrolimus monotherapy.
- No severe adverse effects were reported, suggesting a favorable safety profile for the combination treatment.
Abstract:
Aims: To compare the efficacy of the combination of 0. 05% azelastine and 0.1% tacrolimus eye drops with 0.1% tacrolimus monotherapy in pediatric patients with vernal keratoconjunctivitis (VKC). Methods: Prospective study. Seventy-six patients with VKC were randomized 1:1 into monotherapy group with 0.1% tacrolimus or combination therapy group with 0.1% tacrolimus and 0.05% azelastine. The Ocular Surface Disease Index (OSDI) scores and the signs of conjunctival hyperemia, corneal involvement, and palpebral conjunctiva papillae were assessed at baseline and at 1, 2, and 6 weeks after treatment. Results: Two groups were comparable in age, sex, duration of VKC, OSDI, and clinical signs of VKC at baseline. Significant improvements in OSDI score and clinical signs were observed in both groups at all follow-up visits (all p < 0.001), compared with baseline. The combination therapy group showed a larger decrease in OSDI score from baseline (10.30 ± 0.9) compared with monotherapy group (7.30 ± 0.7, p =0.0085) at 1 week. Greater improvements in conjunctival hyperemia and conjunctival papillae were identified in the combination therapy group, compared with in the monotherapy group, at all follow-up visits (all p < 0.05). The corneal involvement scores in the combination group is significantly lower than the monotherapy group at 2 weeks after the treatment (p = 0.0488). No severe adverse effect was found in either group during the study. Conclusions: Compared with a monotherapy of 0.1% tacrolimus, the combination of 0.05% azelastine and 0.1% tacrolimus eye drops lead to faster and greater improvements in clinical signs and symptoms of vernal keratoconjunctivitis in pediatric patients.
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