Abstract
Purpose :
When creating a lipid eye drop, there is a desire to have a small oil droplet size. This allows a more uniform and stable product and a higher surface area leading to higher bioavailability. In vitro testing was conducted to analyze the oil droplet size and emulsion stability profile of the Blink Triple Care lipid eye drop and 4 marketed lipid eye drops. Additionally, a clinical study was done to evaluate the improvement in overall ocular comfort and overall quality of vision after 30 days of use of Blink® Triple Care lipid eye drop.
Methods :
The droplet size of the lipid phase was measured using a Dynamic light scattering instrument (Malvern Zetasizer Nano). The clinical study was a double masked, bilateral, multi-site, 30 day dispensing trial. Subjects 18-69 years of age were dispensed eye drops for 30 days of use. Endpoints included change from baseline in overall ocular comfort, end of day comfort, overall vision, and end of day vision, all on a 0-100 visual analog scale (VAS).
Results :
Blink Triple Care shows a bimodal distribution of the lipid phase, with 83.8% (V) at 25nm & 16.2% at 195nm. Systane Complete shows a peak at 105nm, Systane Balance at 226nm, Refresh Optive Advanced at 309nm. Soothe XP has a size of ~ 8880 nm using a leaser diffraction technique. The surface areas of the lipid estimated from droplet size and lipid concentration were: Blink Triple Care 6.45, Systane Complete 5.71, Systane Balance 2.65, Refresh Optive Advanced 0.49 and Soothe XP 0.34 cm2 per ml of eye drop. Emulsion instability, expressed as changes in transparency after a sample was centrifuged for 24 hours at 40oC, was 1.4% for the Blink Triple Care, 4.3% for Systane Complete, 121.8% for Systane Balance, 282% for Refresh Optive Advanced, and 4096% for Soothe XP. Sixty-three subjects successfully completed the clinical study. The mean (std) change from baseline after 30 days us of Blink Triple Care was 21.4 (24.5) for overall comfort, 34.6 (26.8) end of the day comfort, 14.2 (22.5) overall vision, and 24.4 (26.0) end of the day vision.
Conclusions :
Blink® Triple Care has the smallest oil droplet size among the lipid eye drops tested, yielding the highest lipid surface area as well as the highest emulsion stability. There was a large improvement in comfort and quality of vision scores, particularly at the end of day after a month of using the Blink® Triple Care lipid drop in a clinical study.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.