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.
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).



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.



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.



Recombinant human lubricin was shown to produce significant improvement in both signs and symptoms of dry eye disease as compared to HA.
Department of Sense Organs, Sapienza University, Rome, Italy.
Alessandro
A
Lambiase
TearLab Research Inc., San Diego, CA; Lμbris BioPharma LLC, Boston, MA, USA. Electronic address: bdsulliv@TearLab.com.
Benjamin D
BD
Sullivan
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.
Tannin A
TA
Schmidt
Schepens Eye Research Institute, Massachusetts Eye and Ear, and Department of Ophthalmology, Harvard Medical School, Boston, MA.
David A
DA
Sullivan
Rhode Island Hospital, Department of Emergency Medicine, Alpert School of Medicine, Brown University, and School of Engineering, Brown University, Providence, RI, USA.
Gregory D
GD
Jay
Lμbris BioPharma LLC, Boston, MA, USA.
Edward R
ER
Truitt
Department of Sense Organs, Sapienza University, Rome, Italy.
Alice
A
Bruscolini
Department of Sense Organs, Sapienza University, Rome, Italy.
Marta
M
Sacchetti
Dompé farmaceutici S.p.A., Milan, Italy. Electronic address: flavio.mantelli@dompe.com.
Flavio
F
Mantelli
D000328:Adult; D000368:Aged; D015352:Dry Eye Syndromes; D006023:Glycoproteins; D006801:Humans; D006820:Hyaluronic Acid; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D013666:Tears; D016896:Treatment Outcome; D000099158:Proteoglycan 4
D006023:Glycoproteins; D006820:Hyaluronic Acid; D009883:Ophthalmic Solutions; D000099158:Proteoglycan 4
PRG4; clinical trial; dry eye disease; hyaluronic acid; lubricin