PLL-g-PEG eye drops in chronic dry eye patients: results from a one-month clinical trial including a controlled adverse environment chamber

Abstract

Purpose : Dry eye disease (DED) is a common, chronic, and multifactorial ocular surface condition characterized by signs and symptoms related to loss of tear film homeostasis and ocular surface changes. Over-the-counter (OTC) lubricants provide symptom relief of DED but are quickly washed out. A formulation of an OTC preservative-free lubricant containing poly(L-lysine) graft poly(ethylene glycol) (PLL-g-PEG) was evaluated for safety, tolerability and efficacy in a one month dosing trial which included assessments with a controlled adverse environment (CAE) chamber.

Methods : 34 DED patients were randomized 2:1 in a controlled, masked trial to PLL-g-PEG 2% eye drops containing glycerin 0.7% and PEG 400 0.3% or a marketed preservative-free control with hydroxypropyl guar and boric acid with PEG 400 and propylene glycol at Visit 1 (V1). Patients returned at Visit 2 and Visit 3 (V3) after 14- and 28-day thrice daily treatment duration, respectively. Patients were evaluated for signs and symptoms (Ora Calibra 0-4 scales) of dry eye at all visits and had 90-minute CAE exposures at V1 (pretreatment) and at V3. The standardized CAE model creates a reproducible environment that challenges the eyes, exacerbating dry eye signs and symptoms.

Results : All qualifying eyes of 28 completed subjects were analyzed (qualifying eyes: PLL-g-PEG n=26, control eyes n=15). Mean change from baseline in inferior corneal fluorescein staining at V3 between groups was 0.47 (p=0.09) (PLL-g-PEG V1 2.30, V3 2.00, p=0.05; control V1 2.27, V3 2.43, p=0.5). Mean V3 change in discomfort by the Ora Calibra scales pre to post CAE was statistically significantly different between groups at -1.81 (p=0.017) (PLL-g-PEG pre-CAE 2.19, post-CAE 3.077, p=0.00057; control pre-CAE 1.40, post-CAE 3.30, p=0.00024). Mean in-CAE discomfort at V3 compared to V1 for PLL-g-PEG was also statistically significantly reduced post-70 minutes (p<0.05), control was not. Both products were well tolerated.

Conclusions : All subjects experienced DED symptom relief in the study. After a 28-day treatment duration, PLL-g-PEG demonstrated improvements in staining and superior symptom relief compared to control. Subjects with DED may benefit from topical ophthalmic products formulated with PLL-g-PEG over currently marketed solutions, especially those exposed to harsher conditions.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.