A Comparison of Comfort/Acceptability and Blur Profile Between PEG/PG and CMC/Glycerin Based Artificial Tears in Both a Dry Eye and Non-Dry Eye Patient Populations

Abstract

Purpose: : To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient populations.

Methods: : This was a controlled, randomized, single drop, acute, double masked, two-period crossover study. 40 patients who signed informed consent were enrolled (20 dry eye patients; 20 non-dry eye = normals). All patients received both products in a randomized fashion with a 24-hr washout between periods. Immediately following administration of the masked artificial tears by the study coordinator, patients were asked to complete a 3 minute blur profile by marking a visual analog scale (VAS) every 30 sec. Following the blur profile determination, patients were asked to evaluate drop comfort, drop acceptability and drop preference on a second VAS. A PEG/PG based tear (SYSTANE^® Lubricant Eye Drops, Alcon) and a CMC/Glycerin based tear (Optive ^TM Lubricant Eye Drops, Allergan) were the comparative drops studied.

Results: : In the dry eye population, the PEG/PG based tear showed statistically significantly less blur at T₀ and T_{30 sec} but no statistical differences beyond those time points. The normal population was similar but with statistically significant differences through T_{60 sec} (T_0, T_{30 sec,} T_{60 sec}) with less blur for the PEG/PG based tear. Overall, there were no statistically significant differences between the two artificial tears on drop comfort, drop acceptability or drop preference. However, a trend was shown for better drop acceptability (p = 0.07) in the dry eye population for the PEG/PG tear, but was not considered clinically different.

Conclusions: : This acute study showed that these two marketed artificial tears (SYSTANE^® and Optive ^TM) were well tolerated and similar in comfort and preference in both dry eye and normal patients. Findings further indicate that Systane exhibits significantly less blur at 30 and 60 seconds following drop administration than Optive ^TM . However, to assess maximum therapeutic benefit, additional studies need to be conducted to evaluate potential differences in clinical efficacy between these products.

Clinical Trial: : www.clinicaltrials.gov NCT00568386

Keywords: cornea: tears/tear film/dry eye • cornea: clinical science