A Comparison of Performance Attributes Between a New Concept Artificial Tear and Systane® Lubricant Eye Drops

Abstract

Abstract: : Purpose: To evaluate the performance characteristics of a new artificial tear (Concept Tear) against Systane® Lubricant Eye Drops under acute dosing regimens. Methods: Two clinical studies were conducted to compare performance attributes of the Concept Tear and Systane. The Concept Tear is multi–dose with buffer ingredients that work in concert to provide preservative efficacy without using a traditional preservative. Like Systane, the Concept Tear contains PEG–400 and propylene glycol as demulcents and HP–Guar as a gelling agent. Study 1: 20 dry eye patients were enrolled in this single center, randomized, double masked, two–period crossover study. To be eligible, patients had to have a diagnosis of dry eye and answer that they needed artificial tears at least "some of the time" due to their dry eye condition. Drops were administered OU per randomization. Drop instillation comfort (10 point scale), overall acceptability (10 point scale) and 3 minute blur profile (50 point scale) comparisons were made. Study 2: 60 patients were enrolled in this single center, randomized, double masked, two period–crossover study. To be eligible, patients had to have a Tear Film Break–Up Time (TFBUT) < 5 sec and demonstrate a deficient Ocular Protection Index (TFBUT/Inter–Blink Interval). 40 µL of the assigned tear were instilled OU per randomization. A masked observer instilled 1µL of sodium fluorescein and measured TFBUT at 5, 10, 15, 20, 30, 45 and 60 minutes post drop instillation. Results: Study 1: No statistically significant differences between the Concept Tear and Systane were seen for drop instillation comfort (Concept Tear mean = 1.0; Systane mean = 1.0), overall drop acceptability (Concept Tear mean = 1.0; Systane mean = 0.8) or 3 minute blur profile (@ t₀ Concept Tear Mean = 20.2; Systane Mean = 21.5; both diminishing to < 0.1 @ 3 minutes). Study 2: TFBUT average at baseline was 2.25. Comparisons between treatments showed that the Concept Tear and Systane were not statistically different (@ t₅ Concept Tear Mean = 3.8; Systane Mean = 4.4). Conclusions: These studies demonstrated that the Concept Tear was similar to Systane under acute dosing conditions.

Keywords: cornea: tears/tear film/dry eye • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • cornea: clinical science