Chiemsee Augen Tagesklinik, Geigelsteinstrasse 26, 83209, Prien, Germany.
Department of Ophthalmology, Technical University of Munich, Munich, Germany.
Graefes Arch Clin Exp Ophthalmol. 2024 Oct;262(10):3261-3271. doi: 10.1007/s00417-024-06414-z. Epub 2024 May 9.
The PERSPECTIVE study was a real-world European, non-interventional, multicenter, observational study that evaluated the effectiveness, tolerability, and safety of ciclosporin A (CsA) 0.1% cationic emulsion (CE) in routine clinical practice as a treatment for adults with severe keratitis and dry eye disease (DED) that remained insufficiently controlled with artificial tears. This sub-analysis examined data from ophthalmology clinics in Germany to provide more precise insights into treatment patterns, outcomes, and clinical decision-making related to CsA 0.1% CE.
Study data were collected from adults starting CsA 0.1% CE (one drop in both eyes at bedtime) and followed up at Week 4, 12, and 24, and Month 12. The primary endpoint was mean change from baseline in corneal fluorescein staining (CFS) score (Oxford Grade Scale) at Month 12. Secondary endpoints examined the severity of ocular signs and symptoms, and adverse events (AEs).
A total of 236 patients from 20 ophthalmology clinics in Germany participated in the PERSPECTIVE study (69.9% female; mean age 60.8 years). Following treatment with CsA 0.1% CE, patients experienced significant reductions in CFS score from Week 4, which were maintained through to Month 12 (P < 0.0001). From baseline, 81.6% of patients experienced an improvement in CFS score at Month 12. CsA 0.1% CE provided significant reductions in the severity of eyelid and conjunctival erythema at Month 12 compared with baseline (P < 0.001), as well as significant reductions in the severity of subjective ocular symptoms (all P ≤ 0.015). Safety data were consistent with the known safety profile of CsA 0.1% CE. Tolerability was rated as "satisfactory," "good," or "very good" by 97.2% of physicians and 95.7% of patients.
Outcomes in Germany were similar to those reported for the overall European study population and are indicative of the treatment results that ophthalmologists may expect to see with CsA 0.1% CE treatment in real-life clinical practice. Treatment with CsA 0.1% CE provided long-term improvements over 12 months and was generally well tolerated.
PERSPECTIVE 研究是一项真实世界的、欧洲的、非干预性的、多中心的观察性研究，评估了环孢素 A（CsA）0.1%阳离子乳液（CE）在常规临床实践中作为治疗成人严重角膜炎和干眼疾病（DED）的有效性、耐受性和安全性，这些患者使用人工泪液治疗后仍未得到充分控制。这项亚分析检查了来自德国眼科诊所的数据，以提供更精确的见解，了解与 CsA 0.1%CE 相关的治疗模式、结果和临床决策。
研究数据来自开始使用 CsA 0.1%CE（每晚每只眼滴一滴）并在第 4、12 和 24 周以及第 12 个月进行随访的成年人。主要终点是第 12 个月时角膜荧光素染色（CFS）评分（牛津量表）与基线相比的平均变化。次要终点评估了眼部体征和症状以及不良事件（AE）的严重程度。
来自德国 20 家眼科诊所的 236 名患者参加了 PERSPECTIVE 研究（69.9%为女性；平均年龄 60.8 岁）。使用 CsA 0.1%CE 治疗后，患者的 CFS 评分从第 4 周开始显著降低，并持续到第 12 个月（P<0.0001）。从基线开始，81.6%的患者在第 12 个月时 CFS 评分得到改善。与基线相比，CsA 0.1%CE 在第 12 个月时显著降低了眼睑和结膜红斑的严重程度（P<0.001），以及主观眼部症状的严重程度（均 P≤0.015）。安全性数据与 CsA 0.1%CE 的已知安全性概况一致。97.2%的医生和 95.7%的患者将耐受性评为“满意”、“良好”或“非常好”。
德国的结果与整个欧洲研究人群报告的结果相似，表明眼科医生在真实临床实践中使用 CsA 0.1%CE 治疗可能会看到的治疗结果。使用 CsA 0.1%CE 治疗在 12 个月内提供了长期改善，且通常耐受性良好。
