M Filippelli1, R dell'Omo2, A Gelso3, M Rinaldi4, S Bartollino2, P Napolitano2, A Russo3, G Campagna5, C Costagliola2. 1. Department of Medicine and Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy. oftelena@gmail.com. 2. Department of Medicine and Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy. 3. "Villa Dei Fiori" Hospital, Acerra, Naples, Italy. 4. Department of Ophthalmology, University Della Campania Luigi Vanvitelli, Naples, Italy. 5. Department of Medical-Surgical Sciences and Translational Medicine, University of Rome "La Sapienza", Rome, Italy.
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").
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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