PubMed:32826644 JSONTXT

{"project":"Zierdiyeerkenaili_800_3","denotations":[{"id":"T1","span":{"begin":402,"end":405},"obj":"DP"},{"id":"T10","span":{"begin":1014,"end":1021},"obj":"CI"},{"id":"T11","span":{"begin":1181,"end":1188},"obj":"CI"},{"id":"T12","span":{"begin":1390,"end":1397},"obj":"CI"},{"id":"T2","span":{"begin":306,"end":309},"obj":"DP"},{"id":"T3","span":{"begin":1504,"end":1507},"obj":"DP"},{"id":"T4","span":{"begin":289,"end":304},"obj":"DP"},{"id":"T5","span":{"begin":10,"end":17},"obj":"CI"},{"id":"T6","span":{"begin":179,"end":186},"obj":"CI"},{"id":"T7","span":{"begin":415,"end":422},"obj":"CI"},{"id":"T8","span":{"begin":503,"end":510},"obj":"CI"},{"id":"T9","span":{"begin":899,"end":906},"obj":"CI"},{"id":"T13","span":{"begin":63,"end":78},"obj":"DP"}],"text":"Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.\nPURPOSE: The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design.\nMETHODS: Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for ≥2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded.\nRESULTS: Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of \u003e5 mm Hg that resulted in an IOP of ≥21 mm Hg in either eye during use of the study product.\nCONCLUSIONS: KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials."}

{"project":"yaoziqian_800_3","denotations":[{"id":"T10","span":{"begin":1181,"end":1188},"obj":"CI"},{"id":"T11","span":{"begin":1390,"end":1397},"obj":"CI"},{"id":"T12","span":{"begin":1504,"end":1507},"obj":"DP"},{"id":"T2","span":{"begin":63,"end":78},"obj":"DP"},{"id":"T3","span":{"begin":179,"end":186},"obj":"CI"},{"id":"T4","span":{"begin":289,"end":304},"obj":"DP"},{"id":"T5","span":{"begin":402,"end":405},"obj":"DP"},{"id":"T6","span":{"begin":415,"end":422},"obj":"CI"},{"id":"T7","span":{"begin":503,"end":510},"obj":"CI"},{"id":"T8","span":{"begin":899,"end":906},"obj":"CI"},{"id":"T9","span":{"begin":1014,"end":1021},"obj":"CI"},{"id":"T13","span":{"begin":10,"end":17},"obj":"CI"},{"id":"T14","span":{"begin":306,"end":309},"obj":"DP"}],"text":"Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.\nPURPOSE: The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design.\nMETHODS: Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for ≥2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded.\nRESULTS: Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of \u003e5 mm Hg that resulted in an IOP of ≥21 mm Hg in either eye during use of the study product.\nCONCLUSIONS: KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials."}