MAY 26, 2020
Cornea/External Disease, Pediatric Ophth/Strabismus
This follow-up study further assessed the safety of cyclosporine A cationic emulsion in patients with pediatric vernal keratoconjunctivitis.
The authors conducted a multicenter, double masked, randomized trial assessing the use of cyclosporine A in children with vernal keratoconjunctivitis. This was an 8-month extension of an original 4-month placebo-controlled study. Main outcomes were to further evaluate safety of cyclosporine A, vernal keratoconjunctivitis symptoms and quality of life. Patients initially assigned to the high dose cyclosporine (QID dosing) or low dose cyclosporine (BID dosing, vehicle BID dosing) were maintained on current regimen. Patients who were initially assigned to the vehicle arm were re-randomized into either high dose or low dose cyclosporine.
Safety of both high- and low-dose cyclosporine A after 12 months was similar to the 4-month results. The most common side effect was irritation or pain with instillation, which only caused 1 patient to withdraw from the study. At 12 months, both study groups show improved symptoms and increased quality of life with no systemic side effects. Rescue topical corticosteroids were not required in over 80% of patients treated with cyclosporine A. Continuous treatment with cyclosporine required less rescue topical corticosteroids and had greater improvement in symptoms compared with intermittent cyclosporine treatment.
This study is an extension of the original 4-month safety trial comparing 2 dosing regimens of cyclosporine with placebo. The 8-month follow-up presented in this paper did not have a control population in order to fully compare sign and symptom improvement over baseline.
Topical cyclosporine is a safe treatment for moderate to severe vernal keratoconjunctivitis. The main side effect is stinging or pain with instillation, but the majority of children on cyclosporine have improved examination findings and report increased quality of life.