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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").
Department of Medicine and Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy. oftelena@gmail.com.
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