Abstract
Purpose :
Propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops are used for the temporary relief of burning and irritation due to dryness of the eye. This study evaluated the effectiveness of PG-HPG nanoemulsion lubricant eye drops in relieving the symptom of sore eyes in subjects with dry eye disease (DED).
Methods :
This post-marketing, prospective, single-arm study was conducted at 4 clinical sites in the US. Subjects (≥18 years) with tear break-up time of ≤10 seconds for both eyes; symptoms of sore eyes as determined by the Impact of Dry Eye on Everyday Living – Symptom Bother (IDEEL-SB) Questionnaire, and a score of 16 to 65 on IDEEL-SB; and those taking cyclosporine or other topical dry eye medications for ≥60 days before enrollment were included. Subjects received the first dose of PG-HPG nanoemulsion lubricant eye drops on day 0 (screening/baseline), and were later required to self-administer one drop (0.6%) qid for 28±2 days. A phone call on day 14±2 and an in-clinic visit on day 28±2 were scheduled. Subjects completed IDEEL-SB on their electronic device at days 0, 14±2, and 28±2. The primary endpoint was the change in sore eyes symptom from day 0 to day 28, evaluated by IDEEL-SB. Relief from sore eye symptom was also assessed using Likert questionnaire (5-point scale: strongly agree to strongly disagree) at day 28.
Results :
In total, 95 subjects were included in the study (mean±standard deviation [SD]: 61.2±13.0 years); with the majority being female (69.5%) and of White race (94.7%). The mean (SD) IDEEL-SB score for sore eye symptom significantly decreased from baseline to day 28 (2.4 [0.7] vs 1.4 [0.9]; mean [SD] change: -1.0 [1.1], p<0.0001). The proportion of subjects with sore eye symptom that bothered them ‘moderately’ or ‘very much’ decreased from baseline (34.0%) to day 14 (10.7%) and day 28 (8.0%). At day 28, relief from sore eyes symptom (agree/strongly agree) was reported by 59.8% of subjects. Three subjects (3.1%) reported treatment-emergent adverse events (non-ocular; infections and infestations).
Conclusions :
The PG-HPG nanoemulsion lubricant eye drop is safe and effective in relieving sore eyes symptom in subjects with DED, over a period of 28 days.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.