Abstract
Purpose :
It is estimated that over 16 million US adults have been diagnosed with dry eye (DE). Artificial tears are often used to treat symptoms of DE, including itching, burning, stinging and general discomfort. Here, we report outcomes from a clinical study of a novel eye drop, compared with an existing comparator.
Methods :
This was a prospective, double-masked, multi-center study approved by Sterling Institutional Review Board (Atlanta, GA). All subjects reported symptoms of ocular dryness in the prior 3 months and/or were habitual users of tear supplements and were not contact lens wearers. Participants were evaluated for dry eye symptoms and signs at visit 1 (baseline), visit 2 (day 7±1) and visit 3 (day 30±2). The primary hypothesis of the study was that the novel eye drops (Blink® Triple Care) are non-inferior to the control drops (Blink® Tears) with respect to change in ocular comfort from baseline at 30-day follow-up based on a non-inferiority margin of -20 points on the ocular comfort Visual Analogue Scale (VAS).
Results :
158 participants were randomized, of which 130 completed the study per protocol, with a mean (SD) age of 47.8 (14.14) years. Mean (95% CI) change in overall comfort scores from baseline at 30-day follow-up in the per-protocol population was 21.4 (15.1–27.7) for the novel lipid-containing eye drop and 10.0 (3.9–16.1) for the comparator. Mean (95% CI) treatment difference was 11.3 (2.6–20.1), meeting requirements for non-inferiority. There was 1 ocular serious adverse event: corneal edema due to trauma, which resulted in discontinuation but was not deemed by the investigator to be related to study eye drops or study procedure.
Conclusions :
The novel eye drop containing a lipid nano-emulsion (Blink® Triple Care) provided a significant improvement in overall comfort and quality of vision and demonstrated non-inferiority to comparator eye drops (Blink® Tears).
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.