Abstract
Purpose
This study aims to investigate the safety and efficacy of short-term treatment for ocular surface disease (OSD) with topical low-dose (1,005 mg) preservative-free hydrocortisone in one hundred patients with and without glaucoma.
Methods
This was an open label non-randomized clinical trial. Patients with OSD with and without primary open-angle glaucoma (POAG) received topical low-dose (1,005 mg) preservative-free hydrocortisone twice daily in each eye for 2 weeks. All patients underwent a complete ophthalmological examination at baseline (T0) and at 1 (T1) and 2 (T2) weeks post-treatment. At each visit, the intraocular pressure (IOP) and the ocular surface disease index (OSDI) questionnaire scores were recorded; the Schirmer test was performed only at T0 and T2.
Results
The OSDI score significantly decreased in both the POAG and no-POAG groups (both p < 0.0001) after hydrocortisone treatment, with no difference between the two groups (p = 0.72). There were no significant differences in IOP and Schirmer test results between T0 and T2 in both treatment groups (p = 0.68 and p = 0.83, respectively).
Conclusions
Topical low-dose (1,005 mg) preservative-free hydrocortisone is safe and effective for improving OSD symptoms both in patients with and without POAG.
Trial registration
The trial was registered at clinicaltrials.gov under NCT04536129 on 01/09/2020 (“retrospectively registered”).
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Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Conceptualization, Ciro Costagliola and Mariaelena Filippelli; methodology, Roberto dell’Omo and Pasquale Napolitano; formal analysis and investigation, Aldo Gelso, Giuseppe Campagna, Alessandra Russo, Michele Rinaldi, and Silvia Bartollino; writing — original draft preparation, Ciro Costagliola and Mariaelena Filippelli; writing — review and editing, Ciro Coatagliola, Mariaelena Filippelli, Roberto dell’Omo, and Giuseppe Campagna; supervision, Ciro Costagliola. All authors read and approved the final manuscript.
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The study protocol was approved by the scientific technical committee of the University of Molise (CTS 11/2019).
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Written informed consent was obtained from all study participants prior to participation.
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Filippelli, M., dell’Omo, R., Gelso, A. et al. Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma. Graefes Arch Clin Exp Ophthalmol 260, 247–253 (2022). https://doi.org/10.1007/s00417-021-05345-3
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DOI: https://doi.org/10.1007/s00417-021-05345-3