Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study.

Abstract

The study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED). This was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18years, with tear breakup time (TBUT) ≤ 10s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 atdays0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2days. Primary endpoints were change from baseline at day28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day28 ± 2; symptom relief (5-point Likert scale) at day28 ± 2, and safety. Of 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day28 for symptoms of aching/sore eyes (change from baseline -1.0 ± 1.1), burning/stinging eyes (change from baseline -1.1 ± 0.9), and tired eyes (change from baseline -1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day28 (change from baseline -0.9 ± 1.0, p < 0.0001). Corneal staining at day28 was comparable to baseline. TBUT improved from baseline to day28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular). PG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28days, with no new safety concerns. ClinicalTrials.gov Identifier, NCT05056155.