Combination of 0.05% Azelastine and 0.1% Tacrolimus Eye Drops in Children With Vernal Keratoconjunctivitis: A Prospective Study

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.

Vernal Keratoconjunctivitis: A Systematic Review

“…In the trial conducted by Zanjani et al [176], the randomization model was not described in detail. The study of Chen et al [180] did not mention how the blinding was performed.…”

Combination Therapy of 0.1% Fluorometholone and 0.05% Azelastine in Eyes with Severe Allergic Conjunctival Diseases: A Randomized Controlled Trial

“…The slit-lamp photography was applied to thoroughly assess the ocular condition at all visits. Conjunctival hyperemia, corneal involvement and palpebral conjunctiva papillae were assessed using a 4-point scale at all visits, as described previously [8,17] (Table 1). The mean sign values were assigned by two expert ophthalmologists independently.…”

“…The mean sign values were assigned by two expert ophthalmologists independently. The Ocular Surface Disease Index (OSDI) questionnaire, consisted of 12 questions involving the frequency of the experienced symptoms, their impact on vision-related QoL, and the presence of any environmental triggers was used at all visits [7,8]. If needed, guardians aided children in completing the OSDI.…”

“…However, patients with severe ACD often require stronger anti-inflammatory agents, such as topical corticosteroids and immunomodulators. While topical cyclosporine and tacrolimus exhibit excellent performance in patients suffering from severe ACD [4][5][6][7][8][9][10], several limitations restrict their administration. First, these nonsteroidal immunomodulators can result in an intense stinging sensation, leading to poor compliance [5,11,12].…”

Morphological and Functional Changes of Meibomian Glands in Pediatric and Adult Patients with Allergic Conjunctivitis

“…Allergic conjunctivitis (AC) is one of the most common ocular disorders in clinical practice [ 1 ], with a 28% incidence in China [ 2 ], a nearly 25% incidence in children in Europe [ 3 ], and between 20% and 30% incidence in the United States [ 4 ]. The major symptoms of AC are itching, swelling, and tearing, and in some severe cases, photophobia and pain could develop due to the involvement of the cornea [ 5 , 6 ]. Patients suffering from AC have a lower health-related quality of life and impaired socioeconomic status [ 7 , 8 , 9 , 10 ].…”