Ophthalmology · 2026
Clobetasol Propionate Ophthalmic Suspension to Treat Ocular Inflammation and Pain after Uncomplicated Cataract Surgery.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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.
Korenfeld Michael S, Levenson Jeffrey, Sadri Ehsan, Liang Eva, Wang Laurene, Nunez Derek J
Аннотация
PURPOSE: To evaluate the efficacy and safety of clobetasol propionate ophthalmic suspension (CPN) 0.05% to treat ocular inflammation and pain after cataract surgery.
DESIGN: Two multicenter, randomized, double-masked, placebo-controlled phase 3 trials, identical in design except for a corneal endothelial cell (EC) safety substudy in the second trial.
PARTICIPANTS: Patients who underwent uncomplicated cataract surgery.
METHODS: After surgery, participants were randomized 1:1 to CPN 0.05% or placebo 1 drop twice daily for 14 days instilled into the operated eye.
MAIN OUTCOME MEASURES: Efficacy outcomes were: (1) the percentage of participants with anterior chamber cell (ACC) count of 0 at postoperative day (POD) 8, maintained through POD 15; (2) the percentage of participants with ocular pain (OP) grade of 0 at POD 4, maintained through POD 15; and (3) inflammation, OP grade, and visual acuity at PODs 4, 8, 15, and 22. Safety outcomes were adverse event reports, ophthalmoscopy, intraocular pressure (IOP), and EC assessments.
RESULTS: Seven hundred forty-eight participants were randomized to receive CPN 0.05% (n = 366) or placebo (n = 382). The demographic and baseline characteristics were well balanced between the 2 groups. CPN 0.05% met the primary end points, producing rapid and sustained clearance of inflammation and absence of OP that was statistically significantly greater than placebo. At POD 15, 58.2% of participants receiving CPN 0.05% and 17.3% of participants receiving placebo had an ACC count of 0 (P < 0.001), and 88.5% of participants receiving CPN 0.05% and 45.8% of participants receiving placebo had an OP grade of 0 (P < 0.001). By POD 4, visual acuity had improved more rapidly in the CPN 0.05% group than in the placebo group (P < 0.001). No rebound of the efficacy parameters was noted on POD 22 after CPN 0.05% was stopped for 1 week. More participants receiving placebo than receiving CPN 0.05% required rescue medications (P < 0.001). CPN 0.05% was well tolerated, with a safety profile similar to that of the placebo. No meaningful IOP increases or corneal EC changes occurred in the group receiving CPN 0.05%.
CONCLUSIONS: CPN 0.05% twice daily for 14 days was safe and rapidly improved inflammation, OP, and visual acuity after cataract surgery.
FINANCIAL DISCLOSURES: Disclosures are in the Footnotes and Disclosures.
DESIGN: Two multicenter, randomized, double-masked, placebo-controlled phase 3 trials, identical in design except for a corneal endothelial cell (EC) safety substudy in the second trial.
PARTICIPANTS: Patients who underwent uncomplicated cataract surgery.
METHODS: After surgery, participants were randomized 1:1 to CPN 0.05% or placebo 1 drop twice daily for 14 days instilled into the operated eye.
MAIN OUTCOME MEASURES: Efficacy outcomes were: (1) the percentage of participants with anterior chamber cell (ACC) count of 0 at postoperative day (POD) 8, maintained through POD 15; (2) the percentage of participants with ocular pain (OP) grade of 0 at POD 4, maintained through POD 15; and (3) inflammation, OP grade, and visual acuity at PODs 4, 8, 15, and 22. Safety outcomes were adverse event reports, ophthalmoscopy, intraocular pressure (IOP), and EC assessments.
RESULTS: Seven hundred forty-eight participants were randomized to receive CPN 0.05% (n = 366) or placebo (n = 382). The demographic and baseline characteristics were well balanced between the 2 groups. CPN 0.05% met the primary end points, producing rapid and sustained clearance of inflammation and absence of OP that was statistically significantly greater than placebo. At POD 15, 58.2% of participants receiving CPN 0.05% and 17.3% of participants receiving placebo had an ACC count of 0 (P < 0.001), and 88.5% of participants receiving CPN 0.05% and 45.8% of participants receiving placebo had an OP grade of 0 (P < 0.001). By POD 4, visual acuity had improved more rapidly in the CPN 0.05% group than in the placebo group (P < 0.001). No rebound of the efficacy parameters was noted on POD 22 after CPN 0.05% was stopped for 1 week. More participants receiving placebo than receiving CPN 0.05% required rescue medications (P < 0.001). CPN 0.05% was well tolerated, with a safety profile similar to that of the placebo. No meaningful IOP increases or corneal EC changes occurred in the group receiving CPN 0.05%.
CONCLUSIONS: CPN 0.05% twice daily for 14 days was safe and rapidly improved inflammation, OP, and visual acuity after cataract surgery.
FINANCIAL DISCLOSURES: Disclosures are in the Footnotes and Disclosures.
Предметные рубрики MeSH
HumansDouble-Blind MethodFemaleVisual AcuityMaleEye PainGlucocorticoidsIntraocular PressureAgedLens Implantation, IntraocularClobetasolOphthalmic SolutionsSuspensionsAnterior ChamberTreatment OutcomeCell CountMiddle AgedPhacoemulsificationUveitis, AnteriorPostoperative PainPostoperative ComplicationsEndophthalmitisCataract ExtractionEndothelium, Corneal