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. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.

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").

Keywords: Intraocular pressure; Ocular surface disease; Open-angle glaucoma; Topical hydrocortisone.

Publication types

  • Clinical Trial

MeSH terms

  • Antihypertensive Agents / therapeutic use
  • Glaucoma* / drug therapy
  • Glaucoma, Open-Angle* / diagnosis
  • Glaucoma, Open-Angle* / drug therapy
  • Humans
  • Hydrocortisone
  • Intraocular Pressure
  • Ocular Hypertension* / drug therapy
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical

Substances

  • Antihypertensive Agents
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical
  • Hydrocortisone

Associated data

  • ClinicalTrials.gov/NCT04536129