Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.
Adv Ther. 2020 Jan;37(1):329-341. doi: 10.1007/s12325-019-01137-8. Epub 2019 Nov 18.
Dry eye disease (DED) is a highly prevalent ocular condition with a significant burden on affected patients. Regardless of the underlying etiology, DED is associated with increased ocular surface inflammation. We investigated the safety and efficacy of a short-term treatment with topical low dose hydrocortisone in patients with chronic DED and ocular surface inflammation.
A total of 60 patients (mean age 51 ± 14 years) with chronic DED and conjunctival hyperemia greater than grade 2 on the Efron scale were included. Patients were randomized to receive either preservative-free hydrocortisone 0.335% (Softacort, Laboratories Thea, France) for 12 days four times daily followed by 2 days twice daily instillation (intense treatment group) or 8 days three times daily followed by 3 days twice daily treatment (standard treatment group). Ocular redness was assessed at baseline, day 14, and day 28. Measurement of intraocular pressure (IOP) and clinical tests to assess signs and symptoms of DED were performed.
Conjunctival hyperemia and Ocular Surface Disease Index (OSDI) significantly decreased in both treatment groups (p < 0.001 each) after hydrocortisone treatment. A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively). IOP did not change in either of the two treatment groups (p = 0.45).
Treatment with low dose hydrocortisone 0.335% reduced ocular inflammation and decreased OSDI score. No change in IOP was observed in either of the two treatment schedules. Because of its good safety profile, low dose hydrocortisone may be an interesting alternative to standard corticosteroid treatment in DED.
Laboratories Thea.
Clinicaltrials.gov registry: NCT03907865.
干眼疾病（DED）是一种高度普遍的眼部疾病，对受影响的患者造成了重大负担。无论潜在病因如何，DED 都与眼表面炎症增加有关。我们研究了短期局部应用低剂量氢化可的松治疗慢性 DED 和眼表面炎症患者的安全性和疗效。
共纳入 60 例（平均年龄 51±14 岁）慢性 DED 患者，埃夫龙（Efron）分级中结膜充血大于 2 级。患者随机接受无防腐剂的氢化可的松 0.335%（法国 Thea 实验室的 Softacort）治疗，12 天内每天 4 次，随后 2 天每天 2 次滴注（强化治疗组）或 8 天内每天 3 次，随后 3 天每天 2 次治疗（标准治疗组）。在基线、第 14 天和第 28 天评估眼部发红。测量眼压（IOP）并进行临床检查以评估 DED 的症状和体征。
在接受氢化可的松治疗后，两组的结膜充血和眼表面疾病指数（OSDI）均显著降低（p<0.001）。治疗开始后 4 周，泪膜厚度显著增加（p=0.03 和 p=0.04）。在这两种治疗方案中，IOP 均无变化（p=0.45）。
低剂量 0.335%氢化可的松治疗可降低眼部炎症和 OSDI 评分。在这两种治疗方案中，IOP 均无变化。由于其良好的安全性，低剂量氢化可的松可能是 DED 标准皮质类固醇治疗的一种有趣替代方案。
法国 Thea 实验室。
Clinicaltrials.gov 注册号：NCT03907865。
