Gioia Neda, Gerson Jeffry, Ryan Robert, Barbour Krista, Poteet Julie, Jennings Brooke, Sharp Matthew, Lowery Ryan, Wilson Jacob, Morde Abhijeet, Rai Deshanie, Padigaru Muralidhara, Periman Laura M
Integrative Vision Corp, Shrewsbury, NJ, United States.
Grin Eye Care, Olathe, KS, United States.
Front Ophthalmol (Lausanne). 2024 Apr 24;4:1362113. doi: 10.3389/fopht.2024.1362113. eCollection 2024.
Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a cycle of tear film instability, tear hyperosmolarity, and inflammation. While artificial tears are the traditional mainstay of treatment, addressing the underlying pathophysiology could relieve symptoms and prevent progression. Increasing evidence indicates a role for oral nutritional supplementation in multiple ophthalmic diseases, including DED. Lutein, zeaxanthin, curcumin, and vitamin D3 have demonstrated protective and anti-inflammatory properties in ocular models. This prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of a proprietary blend of lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) as a daily supplement in adult participants with DED.
Participants were randomized to receive one LCD supplement capsule (lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU) or placebo per day for 8 weeks (LCD, n=77; placebo, n=78). Primary outcomes were changes in tear volume (Schirmer's test) and ocular symptoms (Ocular Surface Disease Index [OSDI]).
The study met its primary endpoints: the LCD group demonstrated significantly better Schirmer's test scores and improvement in overall OSDI score, versus placebo, at Day 56 (p<0.001 for both). Scores for total OSDI, and symptoms and vision domains, significantly improved by Day 14 for LCD versus placebo, (p<0.05 for all) and were maintained to Day 56 (p<0.001). In addition, the LCD group demonstrated significantly improved tear film break-up time (TBUT) and tear film osmolarity, versus placebo, by Day 56 (p<0.001), along with significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation (matrix metalloproteinase-9; p<0.001 for each eye). Total Standard Patient Evaluation of Eye Dryness (SPEED) score, and scores for the frequency and severity domains, were significantly improved by Day 14 for LCD versus placebo (p<0.05 for all) and maintained to Day 56 (p<0.001). There was no difference between groups for artificial tear usage. The supplement was well-tolerated.
Once-daily LCD supplementation significantly improved tear production, stability and quality, reduced ocular surface damage and inflammation, and improved participants' symptoms. LCD supplementation could offer a useful adjunct to artificial tears for patients with DED (NCT05481450).
干眼症(DED)是多因素导致的,其特征是泪膜稳态失衡,引发泪膜不稳定、泪液高渗和炎症的循环。虽然人工泪液是传统的主要治疗方法,但解决潜在的病理生理学问题可以缓解症状并预防病情进展。越来越多的证据表明口服营养补充剂在包括干眼症在内的多种眼科疾病中发挥作用。叶黄素、玉米黄质、姜黄素和维生素D3在眼部模型中已显示出保护和抗炎特性。这项前瞻性、随机、双盲、平行、安慰剂对照研究评估了一种含有叶黄素、玉米黄质异构体、姜黄素和维生素D3(LCD)的专利配方作为每日补充剂对成年干眼症患者的疗效和安全性。
参与者被随机分为两组,每天分别服用一粒LCD补充剂胶囊(叶黄素20毫克、玉米黄质异构体4毫克、姜黄素类化合物200毫克姜黄素、维生素D3 600国际单位)或安慰剂,持续8周(LCD组,n = 77;安慰剂组,n = 78)。主要结局指标是泪液量(泪液分泌试验)和眼部症状(眼表疾病指数[OSDI])的变化。
该研究达到了主要终点:在第56天时,与安慰剂组相比,LCD组的泪液分泌试验得分显著更高,总体OSDI得分也有改善(两者p均<0.001)。与安慰剂组相比,LCD组在第14天时总OSDI得分以及症状和视力领域的得分显著改善(所有p均<0.05),并维持至第56天(p<0.001)。此外,到第56天时,与安慰剂组相比,LCD组的泪膜破裂时间(TBUT)和泪膜渗透压显著改善(p<0.001),角膜和结膜染色也有显著改善(两者p均<0.001),炎症(基质金属蛋白酶-9;每只眼睛p<0.001)也有改善。与安慰剂组相比,LCD组在第14天时总干眼标准患者评估(SPEED)得分以及频率和严重程度领域的得分显著改善(所有p均<0.05),并维持至第56天(p<0.001)。两组在人工泪液使用方面无差异。该补充剂耐受性良好。
每日一次补充LCD显著改善了泪液生成、稳定性和质量,减少了眼表损伤和炎症,并改善了参与者的症状。对于干眼症患者,补充LCD可为人工泪液提供有益的辅助(NCT05481450)。