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Sruthi Srinivasan, Lyndon William Jones, Marc-Matthias (Marc) Schulze, Michel Guillon, JOSEPH TAUBER, Steven Silverstein, Elizabeth Yeu, Manoj Venkiteshwar; Efficacy of a propylene glycol/hydroxypropyl guar-based lubricant eye drop in improving tear stability in patients with dry eye disease. Invest. Ophthalmol. Vis. Sci. 2020;61(7):111.
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© ARVO (1962-2015); The Authors (2016-present)
SYSTANE® Complete (propylene glycol/hydroxypropyl guar [PG/HPG]) lubricant eye drop formulation developed using advanced nano-droplet technology, helps replenish a deficient tear film. This study evaluated the improvement in tear film break up time (TFBUT) after 14 days of treatment with PG/HPG lubricant eye drops in patients with dry eye disease (DED).
This was a Phase IV, multicenter, open-label, single-arm, interventional study. Adult patients with a clinical diagnosis of mild to moderate DED (subtyped into aqueous deficient (ADDE), evaporative dry eye (EDE) and mixed dry eye (MDE)) were included. Eligible patients received one drop of PG/HPG, twice daily. The change from baseline in fluorescein stained tear film break-up time (TFBUT) was assessed at Day 14. Data were analyzed for the overall cohort and by DED subtypes.
Of 134 patients who received the study treatment, 131 completed the study. The median age of the study cohort was 59 (range: 18–87) years, and majority of patients were female (75.4%). Number of patients per subtype were similar (ADE=41; EDE=44; MDE=49). Overall, the median TFBUT increased from 2.68s at baseline to 3.32s at Day 14 (change from baseline= 0.81s; CI for the median = 0.52 -1.18). Subtype analysis showed a median change from baseline in TFBUT of 0.72s for ADDE (CI of median = 0.17-1.22), 1.32s for EDE (CI of median = 0.61-2.26), and 0.55s for MDE (CI of median = 0.07-1.03), at Day 14. The change in TFBUT values were significant overall as well as in the subtypes of DE. The maximum increase in tear film stability was noted in the EDE subgroup (59.2%).
PG/HPG lubricant eye drops increased tear film break up time in patients with DED, with an improvement reported in all dry eye subtypes at Day 14 of treatment. These results show that PG-HPG lubricant eye drops provide an increase in tear film stability in patients with DED.
This is a 2020 ARVO Annual Meeting abstract.
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