Cyclosporine A Cationic Emulsion for Pediatric Vernal Keratoconjunctivitis
Ophthalmology, May 2019
Leonardi et al. evaluated the efficacy and safety of an investigational therapy for severe vernal keratoconjunctivitis (VKC) in children: cyclosporine A (CsA) cationic emulsion (CE). Compared with conventional CsA formulation, the new product (an oil-in-water emulsion) demonstrated better bioavailability. This research indicates that high-dose CsA CE is safe and improves keratitis, its symptoms, and quality of life (QoL) for children with severe VKC.
This phase 3 trial involved 169 pediatric patients with active severe VKC (grade 3 or 4 on the Bonini severity scale) and severe keratitis (corneal fluorescein staining score of 4 or 5 on the modified Oxford scale).
During the four-month study, patients were assigned randomly to receive high-dose treatment (CsA CE 0.1% eyedrops, four times daily), low-dose treatment (CsA CE 0.1% twice daily plus vehicle twice daily), or vehicle four times daily. The primary endpoint was a mean composite score reflecting corneal fluorescein staining, use of rescue medication (dexamethasone 0.1% four times daily), and corneal ulceration. QoL was assessed by a visual analog scale and questionnaire.
For the primary endpoint, differences in least-squares means versus vehicle were significant for the high dose of CsA CE (0.76; p = .007) as well as the low dose (0.67; p = .010); treatment effect was driven mainly by corneal fluorescein staining score. Compared with low-dose CsA CE, the higher dose resulted in larger improvements in photophobia and mucous discharge and much greater improvement in both QoL domains. The need for rescue medication differed significantly between the vehicle group and each active-treatment arm. VKC symptoms and QoL improved in all three groups, and improvement was significant for high-dose treatment versus vehicle.
The original article can be found here.