The FAST Study: Examining Quality of Vision Outcomes in Dry Eye Disease Patients with Severe Keratitis Treated with the Ciclosporin A Cationic Emulsion

Purpose: Examination of the relationship between improvements in dry eye disease (DED) signs and changes in functional visual acuity (FVA) parameters with ciclosporin A 0.1% cationic emulsion (CsA 0.1% CE) treatment. Methods: Adults with DED and severe keratitis were included in a Phase IV, prospective, open-label, multicenter, single-arm, proof-of-concept study. Patients instilled CsA 0.1% CE (one drop daily) and unpreserved artificial tears from baseline through month 3. Primary endpoints examined the change from baseline in corneal fluorescein staining (CFS) score (modified Oxford scale) and any correlation with changes in visual maintenance ratio (VMR) or objective scatter index (OSI) variance. Other endpoints included the change from baseline in CFS score, LogMAR FVA and reporting of adverse events (AEs). Results: Seventeen DED patients were included. Spearman’s correlation analyses showed CFS reductions from baseline were significantly correlated with VMR increases ( ρ = –0.70; P = 0.0017) at month 3 but not with OSI variance changes ( ρ = –0.04; P = 0.8837). Mean CFS score was reduced from 3.8 (baseline) to 1.8 (month 3). CFS reduction significantly correlated with LogMAR FVA changes at month 3 ( ρ = 0.6005; P = 0.0139). Seven patients experienced mild/moderate ocular treatment-related AEs and one had severe eye burn. No discontinuations occurred due to treatment-related AEs and there were no serious or sight-threatening events. Conclusion: DED patients with severe keratitis treated with CsA 0.1% CE demonstrated reductions in CFS score that were strongly and significantly correlated with improvements in quality of vision indicators, including VMR and LogMAR FVA. CsA 0.1% CE was well tolerated throughout the study period.