High-Dose CsA CE Evaluated for Vernal Keratoconjunctivitis
High-dose cyclosporine A cationic emulsion (CsA CE) improved keratitis symptoms and quality of life for children and adolescents with severe vernal keratoconjunctivitis (VKC) better than conventional CsA formulations, according to a phase 3, multicenter double-masked, vehicle-controlled trial.
Participants ranged between 4 and 18 years of age and had active severe VKC and severe keratitis. They were randomized to CsA CE 0.1% (1 mg/mL) eye drops in a high-dose regimen (4 times daily), a low-dose regimen (twice daily CsA + twice daily vehicle), or vehicle QID. Investigators looked at mean composite score (MCS) keratitis (corneal fluorescein staining [CFS] score), rescue medication use (dexamethasone 0.1% QID), and corneal ulceration over 4 months. Among the results:
- Both the high-dose and the low-dose groups had improved MCS compared to vehicle alone (0.76; and 0.67, respectively).
- Effect on MCS was mainly driven by CFS score and to a lesser extent by use of rescue medication.
- All 3 groups experienced improved VKC symptoms and quality of life, but those in the high-dose group experienced significant improvement vs placebo.
- CsA CE was well tolerated.
Leonardi A, Doan S, Amrane M, et al. A Randomized, Controlled Trial of Cyclosporine A Cationic Emulsion in Pediatric Vernal Keratoconjunctivitis: The VEKTIS Study. Ophthalmology. [Published online ahead of print December 26, 2018] doi: 10.1016/j.ophtha.2018.12.027.