期刊
OCULAR SURFACE
卷 15, 期 1, 页码 77-87出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jtos.2016.08.004
关键词
clinical trial; dry eye disease; hyaluronic acid; lubricin; PRG4
资金
- Dompe farmaceutici s.p.a., Italy
- Lmubris BioPharma
- Boston MA
Purpose: The objective of this clinical trial (NCT02507934) was to assess the efficacy and safety of recombinant human lubricin as compared to a 0.18% sodium hyaluronate (HA) eye drop in subjects with moderate dry eye disease (DED). Methods: DEWS Grade 2-3 subjects were randomized to use lubricin (N=19, 51.9 +/- 11.8 years) or HA (N=20, 61.8 +/- 13.3 years). After a saline washout period, subjects administered BID therapy for 7 days, followed by instillation as needed (2-6 drops per eye) for 7 days. Visual analog scale (VAS) including foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia were primary outcomes, with secondary endpoints of corneal fluorescein staining, Schirmer test, tear film breakup time (TFBUT), eyelid and conjunctival erythema and number of instillations compared at day 14. Results: The primary endpoint was met. Lubricin supplementation achieved greater than a 72% reduction from baseline in foreign body sensation (P<.013), burning/ stinging, pain, sticky feeling (P<.0432), blurred vision (P<.0013), and photophobia (P<.011) in at least one eye. Lubricin also showed significant improvement in fluorescein staining (OD/OS: 43.8%/50.0%, vs. 26.5%/ 23.3%, P<.0398, P<.0232), TFBUT (P<.010), SANDE frequency (P<. 0435), eyelid erythema (P<.004), conjunctival erythema (P<.0013), and instillations (P<.04) as compared to HA. No treatment-related adverse events occurred during the investigation. Conclusions: Recombinant human lubricin was shown to produce significant improvement in both signs and symptoms of dry eye disease as compared to HA.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据