Martin Kallab1, Stephan Szegedi1, Nikolaus Hommer1, Hannes Stegmann2, Semira Kaya3, René M Werkmeister2, Doreen Schmidl1, Leopold Schmetterer1,2,4,5,6, Gerhard Garhöfer7. 1. Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. 2. Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria. 3. Department of Ophthalmology, Hietzing Hospital, Vienna, Austria. 4. Singapore Eye Research Institute, Singapore, Singapore. 5. Nanyang Technological University, Singapore, Singapore. 6. Ophthalmology and Visual Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore, Singapore. 7. Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. gerhard.garhoefer@meduniwien.ac.at.
Abstract
PURPOSE: Dry eye disease (DED) is a highly prevalent ocular condition with a significant burden on affected patients. Regardless of the underlying etiology, DED is associated with increased ocular surface inflammation. We investigated the safety and efficacy of a short-term treatment with topical low dose hydrocortisone in patients with chronic DED and ocular surface inflammation. METHODS: A total of 60 patients (mean age 51 ± 14 years) with chronic DED and conjunctival hyperemia greater than grade 2 on the Efron scale were included. Patients were randomized to receive either preservative-free hydrocortisone 0.335% (Softacort, Laboratories Thea, France) for 12 days four times daily followed by 2 days twice daily instillation (intense treatment group) or 8 days three times daily followed by 3 days twice daily treatment (standard treatment group). Ocular redness was assessed at baseline, day 14, and day 28. Measurement of intraocular pressure (IOP) and clinical tests to assess signs and symptoms of DED were performed. RESULTS:Conjunctival hyperemia and Ocular Surface Disease Index (OSDI) significantly decreased in both treatment groups (p < 0.001 each) after hydrocortisone treatment. A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively). IOP did not change in either of the two treatment groups (p = 0.45). CONCLUSION: Treatment with low dose hydrocortisone 0.335% reduced ocular inflammation and decreased OSDI score. No change in IOP was observed in either of the two treatment schedules. Because of its good safety profile, low dose hydrocortisone may be an interesting alternative to standard corticosteroid treatment in DED. FUNDING: Laboratories Thea. TRIAL REGISTRATION: Clinicaltrials.gov registry: NCT03907865.
RCT Entities:
PURPOSE:Dry eye disease (DED) is a highly prevalent ocular condition with a significant burden on affected patients. Regardless of the underlying etiology, DED is associated with increased ocular surface inflammation. We investigated the safety and efficacy of a short-term treatment with topical low dose hydrocortisone in patients with chronic DED and ocular surface inflammation. METHODS: A total of 60 patients (mean age 51 ± 14 years) with chronic DED and conjunctival hyperemia greater than grade 2 on the Efron scale were included. Patients were randomized to receive either preservative-free hydrocortisone 0.335% (Softacort, Laboratories Thea, France) for 12 days four times daily followed by 2 days twice daily instillation (intense treatment group) or 8 days three times daily followed by 3 days twice daily treatment (standard treatment group). Ocular redness was assessed at baseline, day 14, and day 28. Measurement of intraocular pressure (IOP) and clinical tests to assess signs and symptoms of DED were performed. RESULTS:Conjunctival hyperemia and Ocular Surface Disease Index (OSDI) significantly decreased in both treatment groups (p < 0.001 each) after hydrocortisone treatment. A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively). IOP did not change in either of the two treatment groups (p = 0.45). CONCLUSION: Treatment with low dose hydrocortisone 0.335% reduced ocular inflammation and decreased OSDI score. No change in IOP was observed in either of the two treatment schedules. Because of its good safety profile, low dose hydrocortisone may be an interesting alternative to standard corticosteroid treatment in DED. FUNDING: Laboratories Thea. TRIAL REGISTRATION: Clinicaltrials.gov registry: NCT03907865.
Authors: M Filippelli; R dell'Omo; A Gelso; M Rinaldi; S Bartollino; P Napolitano; A Russo; G Campagna; C Costagliola Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-08-18 Impact factor: 3.117
Authors: Carlo Cagini; Alessio Muzi; Greta Castellucci; Giulia Ragna; Marco Lupidi; Husam B R Alabed; Roberto Maria Pellegrino Journal: Int J Clin Pract Date: 2021-10-26 Impact factor: 3.149