A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients with Moderate Dry Eye Disease

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• 作者：Alessandro Lambiase ; MD ; PhD¹ ; ^&lowast ; ; Benjamin D. Sullivan ; PhD² ; ³ ; ^&lowast ; ; ^{bdsulliv@TearLab.com} ; Tannin A. Schmidt ; PhD³ ; ⁴ ; David A. Sullivan ; PhD⁵ ; Gregory D. Jay ; MD ; PhD⁶ ; Edward R. Truitt III ; JD³ ; Alice Bruscolini ; MD ; PhD¹ ; Marta Sacchetti ; MD ; PhD¹ ; Flavio Mantelli ; MD ; PhD⁷ ; ^{flavio.mantelli@dompe.com}
• 关键词：clinical trial ; dry eye disease ; hyaluronic acid ; lubricin ; PRG4
• 刊名：The Ocular Surface
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：15
• 期：1
• 页码：77-87
• 全文大小：410 K
• 卷排序：15

文摘

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).MethodsDEWS 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.ResultsThe 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.ConclusionsRecombinant human lubricin was shown to produce significant improvement in both signs and symptoms of dry eye disease as compared to HA.