Clinical experience with preservative free low-dose hydrocortisone for the management of inflammation in dry eye disease

Purpose To describe real-world experience after adding preservative-free hydrocortisone 0.335% to manage ocular surface inflammation in patients with dry eye disease (DED) who required combined therapy. Methods This retrospective, multicenter, international case series evaluated 27 patients diagnosed with DED that was poorly controlled on a regimen of ocular lubricants or multimodal treatment and were prescribed topical preservative-free hydrocortisone 0.335% for combination therapy. Similarity and quality of data collection were the main inclusion criteria for inclusion in the study. Data are reported as mean, standard deviation and range for quantitative variables at baseline and the last follow-up visit after initiating low-dose hydrocortisone therapy. Intergroup data were compared using the Kolmogorov–Smirnov test followed by the nonparametric Mann-Whitney test. P < 0.05 was considered statistically significant. Results The severity of DED ranged from mild to severe, with cases that included mixed etiology and DED related to chronic graft versus host disease. Mean intraocular pressure (IOP) was 14.77 ± 2.48 mmHg at baseline and 14.75 ± 2.52 mmHg at 2 weeks after initiating low-dose hydrocortisone therapy. There were no cases of an IOP spike during treatment with the preservative-free low-dose hydrocortisone. The mean ocular surface disease index (OSDI) score decreased statistically significantly from 27.44 ± 15.80 at baseline to 19.10 ± 10.84 at 2 weeks after initiating low-dose hydrocortisone therapy ( P < 0.05). There was a clinically significant improvement in these parameters as indicated by Schirmer tests I and II, grading of conjunctival hyperemia and corneal staining. After addition of low-dose preservative-free hydrocortisone, treatment was successful in all cases, with 18 (66.7%) defined as resolved and 9 (33.3%) defined as stable. None of patients were intolerant to the preservative-free low-dose corticosteroid formulation. Conclusion In patients with DED recalcitrant to medical therapy, addition of low-dose, preservative-free hydrocortisone in combination therapy with ocular lubricants improved the signs and symptoms of mild to severe cases without inciting adverse events such as an IOP spike or ocular infections. Treatment was considered successful in all cases.