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.

Autor: Lambiase A; Department of Sense Organs, Sapienza University, Rome, Italy., Sullivan BD; TearLab Research Inc., San Diego, CA; Lμbris BioPharma LLC, Boston, MA, USA. Electronic address: bdsulliv@TearLab.com., Schmidt TA; Lμbris BioPharma LLC, Boston, MA, USA; Faculty of Kinesiology, Human Performance Laboratory, and Centre for Bioengineering Research and Education, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada., Sullivan DA; Schepens Eye Research Institute, Massachusetts Eye and Ear, and Department of Ophthalmology, Harvard Medical School, Boston, MA., Jay GD; Rhode Island Hospital, Department of Emergency Medicine, Alpert School of Medicine, Brown University, and School of Engineering, Brown University, Providence, RI, USA., Truitt ER 3rd; Lμbris BioPharma LLC, Boston, MA, USA., Bruscolini A; Department of Sense Organs, Sapienza University, Rome, Italy., Sacchetti M; Department of Sense Organs, Sapienza University, Rome, Italy., Mantelli F; Dompé farmaceutici S.p.A., Milan, Italy. Electronic address: flavio.mantelli@dompe.com.
Jazyk: angličtina
Zdroj: The ocular surface [Ocul Surf] 2017 Jan; Vol. 15 (1), pp. 77-87. Date of Electronic Publication: 2016 Sep 08.
DOI: 10.1016/j.jtos.2016.08.004
Abstrakt: 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.
(Copyright © 2016 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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