Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial
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.
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.
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).
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.
Clinicaltrials.gov registry: NCT03907865.
KeywordsCorticosteroid Dry eye disease Hydrocortisone Inflammation Ophthalmology Preservative free Tear film
The present study was sponsored by Laboratories Thea, France. The Rapid Service Fees were funded by Laboratories Thea. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Doreen Schmidl is a consultant for Laboratories Thea. Leopold Schmetterer is a consultant for Laboratories Thea. Gerhard Garhöfer is a consultant for Laboratories Thea. Martin Kallab, Stephan Szegedi, Nikolaus Hommer, Hannes Stegmann, Semira Kaya, and René M. Werkmeister declare that they have no conflict of interest.
Compliance with Ethics Guidelines
The study protocol was approved by the Ethics Committee of the Medical University of Vienna. The study was performed in adherence to the guidelines of the Declaration of Helsinki including all revisions as well as Good Clinical Practice guidelines. Written informed consent was obtained from all study participants prior to participation and Springer’s policy concerning informed consent has been followed.
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