Impact of propylene glycol-hydroxypropyl guar nanoemulsion eyedrops on mild to moderate dry eye

Abstract

Aim: To evaluate symptom relief in Argentinian patients with mild to moderate dry eye disease (EOS) treated with propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane® Complete) eye drops.

Methods: A phase IV single-arm, open-label, prospective, interventional clinical trial was performed in 40 EOS patients. The primary endpoint was the mean difference in the Ocular Surface Disease Index (OSDI) in mild and moderate EOS sufferers after 28 days of treatment. The secondary endpoint was noninvasive tear breakup time (NBUT) in mild and moderate EOS sufferers at 14 and 28 days.

Results: A moderate negative correlation was found between OSDI score and NBUT (Spearman rank correlation rho = -0.26, p-value <0.001). Baseline OSDI score was on average 21.5 points (95% CI 18.8 – 24.1), after 14 days of treatment it was 16.2 (95% CI 13.6 – 18.8), and after 28 days it was 13.4 (95% CI 11.85 – 15.69). When comparing the baseline OSDI and the OSDI at 28 days, the average decrease was 8.06 points (95% CI 6.88 – 9.24, p-value <0.001). At baseline, NBUT was 5.94 seconds (95% CI 1.49 - 10.4), at 14 days it was 7.00 seconds (95% CI 2.74 - 11.3), and at 28 days it was 7.61 seconds (95% CI 3.14 – 12.1). Between baseline and 28 days of treatment, NBUT increased by 1.68 seconds (95% CI 0.79 – 2.57, p-value <0.0001).

Conclusion: The PG-HPG nanoemulsion provided symptom relief after instillation four times a day for 28 days in an Argentinian population of patients with mild and moderate EOS.