Intraocular Pressure During Short-Term Topical or Systemic Corticosteroid Treatment: Analysis of 3 Randomized Clinical Trials.

Abstract

Increased intraocular pressure (IOP) is a known adverse effect of corticosteroid use and may lead to corticosteroid-induced glaucoma. However, clinical evidence on the impact of topical corticosteroids (TCS) on IOP is limited. To evaluate changes in IOP during short-term treatment with periocular and whole-body TCS (studies 1 and 2) and systemic corticosteroids (study 3). This report includes the findings of 3 randomized clinical trials (RCTs) conducted at Herlev-Gentofte Hospital, University of Copenhagen (Denmark). Study 1 was an open-label RCT of patients with periocular atopic dermatitis (AD) and healthy controls, conducted from October 2021 to August 2023. Study 2 was a double-blind active comparator RCT of patients with AD conducted from September 2019 to March 2021. Study 3 was a double-blind RCT of male individuals with overweight or obesity and without diabetes conducted from December 2019 to June 2021. Data were analyzed from October 2024 to April 2025. In study 1, patients with AD and healthy controls applied periocular hydrocortisone (1.0%) cream or hydrocortisone-17-butyrate (0.1%) cream for 4 weeks; another group of healthy controls received no treatment. In study 2, patients with AD completed 2 weeks of whole-body betamethasone 17-valerate (0.1%) plus placebo or tacrolimus (0.1%) twice daily, followed by 4 weeks of twice-weekly treatment. In study 3, patients with AD received 10 days of oral placebo or prednisolone (50 mg) or prednisolone (50 mg) plus curcumin (400 mg). Change in IOP-the primary end point in study 1 and a predefined secondary end point in studies 2 and 3. Study 1 included 24 patients, 8 with periocular atopic dermatitis (AD) and 16 healthy controls; study 2 included 36 patients with AD; and study 3 included 24 male individuals with overweight or obesity and without diabetes. The analysis of the 3 studies included a total of 84 participants (34 female [40.5%] and 50 male [59.5%] patients) with comparable baseline characteristics (mean [SD] age, 32 [9], 28 [10], and 46 [14] years). In study 1, right eye IOP significantly decreased in patients with AD after treatment compared to untreated controls (-2.5 mm Hg; 95% CI, -3.9 to -1.1 mm Hg; P = .002). No significant changes were observed in the left eye or among treated healthy controls. In studies 2 and 3, IOP remained stable, with no significant changes. In these 3 RCTs, short-term corticosteroid use, whether topical or systemic, did not appear to increase IOP. These findings support the ocular safety of short-term corticosteroid use. EU Clinical Trials Register Identifier: 2020-000252-35; ClinicalTrials.gov Identifier: NCT04114097 and NCT04315350.