JAMA dermatology · 2026
Intraocular Pressure During Short-Term Topical or Systemic Corticosteroid Treatment: Analysis of 3 Randomized Clinical Trials.
Клиническое исследование IV фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Amiri Diva, Hellmann Pernille H, Thyssen Jacob P, Skov Lone, Kolko Miriam, Gether Lise
Аннотация
IMPORTANCE: 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.
OBJECTIVE: To evaluate changes in IOP during short-term treatment with periocular and whole-body TCS (studies 1 and 2) and systemic corticosteroids (study 3).
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTIONS: 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).
MAIN OUTCOME: Change in IOP-the primary end point in study 1 and a predefined secondary end point in studies 2 and 3.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATIONS: EU Clinical Trials Register Identifier: 2020-000252-35; ClinicalTrials.gov Identifier: NCT04114097 and NCT04315350.
OBJECTIVE: To evaluate changes in IOP during short-term treatment with periocular and whole-body TCS (studies 1 and 2) and systemic corticosteroids (study 3).
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTIONS: 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).
MAIN OUTCOME: Change in IOP-the primary end point in study 1 and a predefined secondary end point in studies 2 and 3.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATIONS: EU Clinical Trials Register Identifier: 2020-000252-35; ClinicalTrials.gov Identifier: NCT04114097 and NCT04315350.