BMJ open · 2026
Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicentre, randomised, placebo-controlled, double-masked clinical studies.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Schwartz Andrew, Wellish Kent, Zaman Fiaz, Jong Kevin, Sadri Ehsan, Martel Joseph, Peace James, Korenfeld Michael
Аннотация
OBJECTIVE: To assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery.
DESIGN: Two independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies.
SETTING: The CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA.
PARTICIPANTS: Patients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery INTERVENTIONS: Participants were randomised to either clobetasol or placebo four times a day for 14 days. Follow-up visits occurred on days 3, 8, 15 and 29.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the proportion of patients with anterior chamber cell (ACC) grade 0 on day 8. A key secondary efficacy endpoint was the proportion of patients with a Visual Analogue Scale (VAS) pain score of 0 on day 8. Safety was also assessed.
RESULTS: 426 patients were randomised: 281 to the clobetasol arm and 145 to the placebo arm. The proportion of patients with ACC of 0 at day 8 was significantly superior with clobetasol (37.8% vs 18.1%; odds ratio [OR] 2.8; p<0.0001). The percentage of patients with a VAS pain score of 0 on day 8 was greater with clobetasol (54.7% vs 36.5%; OR 2.1; p=0.0005). Related treatment-emergent adverse events were reported in 3.9% of patients on clobetasol and 5.5% on placebo.
CONCLUSIONS: Clobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery.
TRIAL REGISTRATION NUMBERS: CLOSE-1 (NCT04246801) and CLOSE-2 (NCT04249076).
DESIGN: Two independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies.
SETTING: The CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA.
PARTICIPANTS: Patients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery INTERVENTIONS: Participants were randomised to either clobetasol or placebo four times a day for 14 days. Follow-up visits occurred on days 3, 8, 15 and 29.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the proportion of patients with anterior chamber cell (ACC) grade 0 on day 8. A key secondary efficacy endpoint was the proportion of patients with a Visual Analogue Scale (VAS) pain score of 0 on day 8. Safety was also assessed.
RESULTS: 426 patients were randomised: 281 to the clobetasol arm and 145 to the placebo arm. The proportion of patients with ACC of 0 at day 8 was significantly superior with clobetasol (37.8% vs 18.1%; odds ratio [OR] 2.8; p<0.0001). The percentage of patients with a VAS pain score of 0 on day 8 was greater with clobetasol (54.7% vs 36.5%; OR 2.1; p=0.0005). Related treatment-emergent adverse events were reported in 3.9% of patients on clobetasol and 5.5% on placebo.
CONCLUSIONS: Clobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery.
TRIAL REGISTRATION NUMBERS: CLOSE-1 (NCT04246801) and CLOSE-2 (NCT04249076).