Alessandro Lambiase1, Benjamin D Sullivan2, Tannin A Schmidt3, David A Sullivan4, Gregory D Jay5, Edward R Truitt6, Alice Bruscolini1, Marta Sacchetti1, Flavio Mantelli7. 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.
RCT Entities:
PURPOSE: The objective of this clinical trial (NCT02507934) was to assess the efficacy and safety of recombinant humanlubricin 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 humanlubricin was shown to produce significant improvement in both signs and symptoms of dry eye disease as compared to HA.
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