Format

Send to

Choose Destination
Ocul Surf. 2017 Jan;15(1):77-87. doi: 10.1016/j.jtos.2016.08.004. Epub 2016 Sep 8.

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.

Author information

1
Department of Sense Organs, Sapienza University, Rome, Italy.
2
TearLab Research Inc., San Diego, CA; Lμbris BioPharma LLC, Boston, MA, USA. Electronic address: bdsulliv@TearLab.com.
3
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.
4
Schepens Eye Research Institute, Massachusetts Eye and Ear, and Department of Ophthalmology, Harvard Medical School, Boston, MA.
5
Rhode Island Hospital, Department of Emergency Medicine, Alpert School of Medicine, Brown University, and School of Engineering, Brown University, Providence, RI, USA.
6
Lμbris BioPharma LLC, Boston, MA, USA.
7
Dompé farmaceutici S.p.A., Milan, Italy. Electronic address: flavio.mantelli@dompe.com.

Abstract

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.

KEYWORDS:

PRG4; clinical trial; dry eye disease; hyaluronic acid; lubricin

PMID:
27614318
DOI:
10.1016/j.jtos.2016.08.004
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center